Anesthesiology

Anesthesiology

Anesthesiology is a practice in medicine that provides relief of pain and total care of a patient before, during, and after surgery. The FDA regulates devices used in the practice of anesthesiology under CFR Title 21 Part 868, and the devices are categorized into four subparts.

Anesthesiology Diagnostic Devices

Anesthesiology Diagnostic Devices

Manual algesimeter.

§868.1030
Manual algesimeter.
Identification. A manual algesimeter is a mechanical device intended to determine a patient's sensitivity to pain after administration of an anesthetic agent, e.g., by pricking with a sharp point.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Powered algesimeter.

§868.1040
Powered algesimeter.
Identification. A powered algesimeter is a device using electrical stimulation intended to determine a patient's sensitivity to pain after administration of an anesthetic agent.
Classification. Class II (performance standards).

Argon gas analyzer.

§868.1075
Argon gas analyzer.
Identification. An argon gas analyzer is a device intended to measure the concentration of argon in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as mass spectrometry or thermal conductivity.
Classification. Class II (performance standards).

Arterial blood sampling kit.

§868.1100
Arterial blood sampling kit.
Identification. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Indwelling blood oxyhemoglobin concentration analyzer.

§868.1120
Indwelling blood oxyhemoglobin concentration analyzer.
Identification. An indwelling blood oxyhemoglobin concentration analyzer is a photoelectric device used to measure, in vivo, the oxygen-carrying capacity of hemoglobin in blood to aid in determining the patient's physiological status.
Classification. Class III (premarket approval).

Indwelling blood carbon dioxide partial pressure (PCO2) analyzer.

§868.1150
Indwelling blood carbon dioxide partial pressure (PCO2) analyzer.
Identification. An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.

Indwelling blood hydrogen ion concentration (pH) analyzer.

§868.1170
Indwelling blood hydrogen ion concentration (pH) analyzer.
Identification. An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter-tip pH electrode and that is used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient's acid-base balance.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.

Indwelling blood oxygen partial pressure (PO2) analyzer.

§868.1200
Indwelling blood oxygen partial pressure (PO2) analyzer.
Identification. An indwelling blood oxygen partial pressure (PO2) analyzer is a device that consists of a catheter-tip PO2 transducer (e.g., PO2 electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.

Carbon dioxide gas analyzer.

§868.1400
Carbon dioxide gas analyzer.
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.
Classification. Class II (performance standards).

Carbon monoxide gas analyzer.

§868.1430
Carbon monoxide gas analyzer.
Identification. A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.
Classification. Class II (performance standards).

Enflurane gas analyzer.

§868.1500
Enflurane gas analyzer.
Identification. An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.
Classification. Class II (performance standards).

Gas collection vessel.

§868.1575
Gas collection vessel.
Identification. A gas collection vessel is a container-like device intended to collect a patient's exhaled gases for subsequent analysis. It does not include a sampling pump.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Halothane gas analyzer.

§868.1620
Halothane gas analyzer.
Identification. A halothane gas analyzer is a device intended to measure the concentration of halothane anesthetic in a gas mixture. The device may use techniques such as mass spectrometry or absorption of infrared or ultraviolet radiation.
Classification. Class II (performance standards).

Helium gas analyzer.

§868.1640
Helium gas analyzer.
Identification. A helium gas analyzer is a device intended to measure the concentration of helium in a gas mixture during pulmonary function testing. The device may use techniques such as thermal conductivity, gas chromatography, or mass spectrometry.
Classification. Class II (performance standards).

Neon gas analyzer.

§868.1670
Neon gas analyzer.
Identification. A neon gas analyzer is a device intended to measure the concentration of neon in a gas mixture exhaled by a patient. The device may use techniques such as mass spectrometry or thermal conductivity.
Classification. Class II (performance standards).

Nitrogen gas analyzer.

§868.1690
Nitrogen gas analyzer.
Identification. A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in respiratory gases to aid in determining a patient's ventilatory status. The device may use techniques such as gas chromatography or mass spectrometry.
Classification. Class II (performance standards).

Nitrous oxide gas analyzer.

§868.1700
Nitrous oxide gas analyzer.
Identification. A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry.
Classification. Class II (performance standards).

Oxygen gas analyzer.

§868.1720
Oxygen gas analyzer.
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.
Classification. Class II (performance standards).

Oxygen uptake computer.

§868.1730
Oxygen uptake computer.
Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.
Classification. Class II (performance standards).

Pressure plethysmograph.

§868.1750
Pressure plethysmograph.
Identification. A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box.
Classification. Class II (performance standards).

Volume plethysmograph.

§868.1760
Volume plethysmograph.
Identification. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.
Classification. Class II (performance standards).

Inspiratory airway pressure meter.

§868.1780
Inspiratory airway pressure meter.
Identification. An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient's airway during maximal inspiration.
Classification. Class II (performance standards).

Rhinoanemometer.

§868.1800
Rhinoanemometer.
Identification. A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient's nasal passages.
Classification. Class II (performance standards).

Diagnostic spirometer.

§868.1840
Diagnostic spirometer.
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.
Classification. Class II (performance standards).

Monitoring spirometer.

§868.1850
Monitoring spirometer.
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.
Classification. Class II (performance standards).

Peak-flow meter for spirometry.

§868.1860
Peak-flow meter for spirometry.
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.
Classification. Class II (performance standards).

Gas volume calibrator.

§868.1870
Gas volume calibrator.
Identification. A gas volume calibrator is a device that is intended for medical purposes and that is used to calibrate the output of gas volume measurement instruments by delivering a known gas volume.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Pulmonary-function data calculator.

§868.1880
Pulmonary-function data calculator.
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.
Classification. Class II (performance standards).

Predictive pulmonary-function value calculator.

§868.1890
Predictive pulmonary-function value calculator.
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.
Classification. Class II (performance standards).

Diagnostic pulmonary-function interpretation calculator.

§868.1900
Diagnostic pulmonary-function interpretation calculator.
Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.
Classification. Class II (performance standards).

Esophageal stethoscope.

§868.1910
Esophageal stethoscope.
Identification. An esophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to enable the user to listen to heart and breath sounds.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 868.9.

Esophageal stethoscope with electrical conductors.

§868.1920
Esophageal stethoscope with electrical conductors.
Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.
Classification. Class II (performance standards).

Stethoscope head.

§868.1930
Stethoscope head.
Identification. A stethoscope head is a weighted chest piece used during anesthesia to listen to a patient's heart, breath, and other physiological sounds.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Switching valve (ploss).

§868.1965
Switching valve (ploss).
Identification. A switching valve (ploss) is a three-way valve located between a stethoscope placed over the heart, a blood pressure cuff, and an earpiece. The valve allows the user to eliminate one sound channel and listen only to a patient's heart or korotkoff (blood pressure) sounds through the other channel.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Water vapor analyzer.

§868.1975
Water vapor analyzer.
Identification. A water vapor analyzer is a device intended to measure the concentration of water vapor in a patient's expired gases by using techniques such as mass spectrometry.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Anesthesiology Monitoring Devices

Anesthesiology Monitoring Devices

Ultrasonic air embolism monitor.

§868.2025
Ultrasonic air embolism monitor.
Identification. An ultrasonic air embolism monitor is a device used to detect air bubbles in a patient's blood stream. It may use Doppler or other ultrasonic principles.
Classification. Class II (performance standards).

Bourdon gauge flowmeter.

§868.2300
Bourdon gauge flowmeter.
Identification. A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Uncompensated thorpe tube flowmeter.

§868.2320
Uncompensated thorpe tube flowmeter.
Identification. An uncompensated thorpe tube flowmeter is a device intended for medical purposes that is used to indicate and control gas flow rate accurately. The device includes a vertically mounted tube and is calibrated when the outlet of the flowmeter is open to the atmosphere.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Compensated thorpe tube flowmeter.

§868.2340
Compensated thorpe tube flowmeter.
Identification. A compensated thorpe tube flowmeter is a device intended for medical purposes that is used to control and measure gas flow rate accurately. The device includes a vertically mounted tube, with the outlet of the flowmeter calibrated to a reference pressure.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Gas calibration flowmeter.

§868.2350
Gas calibration flowmeter.
Identification. A gas calibration flowmeter is a device intended for medical purposes that is used to calibrate flowmeters and accurately measure gas flow.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Breathing frequency monitor.

§868.2375
Breathing frequency monitor.
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in 868.2377.
Classification. Class II (performance standards).

Apnea monitor.

§868.2377
Apnea monitor.
Identification. An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.

Nitric oxide analyzer.

§868.2380
Nitric oxide analyzer.
Identification. The nitric oxide analyzer is a device intended to measure the concentration of nitric oxide in respiratory gas mixtures during administration of nitric oxide.
Classification. Class II. The special control for this device is FDA's Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.

Nitrogen dioxide analyzer.

§868.2385
Nitrogen dioxide analyzer.
Identification. The nitrogen dioxide analyzer is a device intended to measure the concentration of nitrogen dioxide in respiratory gas mixtures during administration of nitric oxide.
Classification. Class II. The special control for this device is FDA's Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.

Lung water monitor.

§868.2450
Lung water monitor.
Identification. A lung water monitor is a device used to monitor the trend of fluid volume changes in a patient's lung by measuring changes in thoracic electrical impedance (resistance to alternating current) by means of electrodes placed on the patient's chest.
Classification. Class III (premarket approval).

Cutaneous carbon dioxide (PcCO2) monitor.

§868.2480
Cutaneous carbon dioxide (PcCO2) monitor.
Identification. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA. See 868.1(e) for the availability of this guidance document.

Cutaneous oxygen (PcO2) monitor.

§868.2500
Cutaneous oxygen (PcO2) monitor.
Identification. A cutaneous oxygen (PcO2) monitor is a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) placed on the patient's skin that is intended to monitor relative changes in the cutaneous oxygen tension.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA. See 868.1(e) for the availability of this guidance document.

Pneumotachometer.

§868.2550
Pneumotachometer.
Identification. A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressure differential across a known resistance. The device may use a set of capillaries or a metal screen for the resistive element.
Classification. Class II (performance standards).

Airway pressure monitor.

§868.2600
Airway pressure monitor.
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.
Classification. Class II (performance standards).

Gas pressure gauge.

§868.2610
Gas pressure gauge.
Identification. A gas pressure gauge (e.g., bourdon tube pressure gauge) is a device intended for medical purposes that is used to measure gas pressure in a medical gas delivery system.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Gas pressure calibrator.

§868.2620
Gas pressure calibrator.
Identification. A gas pressure calibrator is a device intended for medical purposes that is used to calibrate pressure-measuring instruments by generating a known gas pressure.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Pressure regulator.

§868.2700
Pressure regulator.
Identification. A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Electrical peripheral nerve stimulator.

§868.2775
Electrical peripheral nerve stimulator.
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.
Classification. Class II (performance standards).

Differential pressure transducer.

§868.2875
Differential pressure transducer.
Identification. A differential pressure transducer is a two-chambered device intended for medical purposes that is often used during pulmonary function testing. It generates an electrical signal for subsequent display or processing that is proportional to the difference in gas pressures in the two chambers.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Gas flow transducer.

§868.2885
Gas flow transducer.
Identification. A gas flow transducer is a device intended for medical purposes that is used to convert gas flow rate into an electrical signal for subsequent display or processing.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Gas pressure transducer.

§868.2900
Gas pressure transducer.
Identification. A gas pressure transducer is a device intended for medical purposes that is used to convert gas pressure into an electrical signal for subsequent display or processing.
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

Anesthesiology Therapeutic Devices

Anesthesiology Therapeutic Devices

Emergency airway needle.

§868.5090
Emergency airway needle.
Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.
Classification. Class II (performance standards).

Nasopharyngeal airway.

§868.5100
Nasopharyngeal airway.
Identification. A nasopharyngeal airway is a device used to aid breathing by means of a tube inserted into a patient's pharynx through the nose to provide a patent airway.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Oropharyngeal airway.

§868.5110
Oropharyngeal airway.
Identification. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Device to relieve acute upper airway obstruction.

§868.5115
Device to relieve acute upper airway obstruction.
Identification. The device is a raised, rounded pad that, in the event of choking on a foreign body, can be applied to the abdomen and pushed upward to generate expulsion pressure to remove the obstruction to relieve acute upper airway obstruction.
Classification. Class II (special controls) (Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to 868.9.

Anesthesia conduction catheter.

§868.5120
Anesthesia conduction catheter.
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.
Classification. Class II (performance standards).

Anesthesia conduction filter.

§868.5130
Anesthesia conduction filter.
Identification. An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.
Classification. Class II (performance standards).

Anesthesia conduction kit.

§868.5140
Anesthesia conduction kit.
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.
Classification. Class II (performance standards).

Anesthesia conduction needle.

§868.5150
Anesthesia conduction needle.
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
Classification. Class II (performance standards).

Gas machine for anesthesia or analgesia.

§868.5160
Gas machine for anesthesia or analgesia.
Gas machine for anesthesia(1) Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. (2) Classification. Class II (performance standards).
Gas machine for analgesia(1) Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide). (2) Classification. Class II (performance standards).

Nitric oxide administration apparatus.

§868.5165
Nitric oxide administration apparatus.
Identification. The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.
Classification. Class II. The special control for this device is FDA's Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.

Laryngotracheal topical anesthesia applicator.

§868.5170
Laryngotracheal topical anesthesia applicator.
Identification. A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient's laryngotracheal area.
Classification. Class II (performance standards).

Rocking bed.

§868.5180
Rocking bed.
Identification. A rocking bed is a device intended for temporary use to help patient ventilation (breathing) by repeatedly tilting the patient, thereby using the weight of the abdominal contents to move the diaphragm.
Classification. Class II (performance standards).

Blow bottle.

§868.5220
Blow bottle.
Identification. A blow bottle is a device that is intended for medical purposes to induce a forced expiration from a patient. The patient blows into the device to move a column of water from one bottle to another.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Anesthesia breathing circuit.

§868.5240
Anesthesia breathing circuit.
Identification. An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Breathing circuit circulator.

§868.5250
Breathing circuit circulator.
Identification. A breathing circuit circulator is a turbine device that is attached to a closed breathing circuit and that is intended to circulate anesthetic gases continuously by maintaining the unidirectional valves in an open position and reducing mechanical dead space and resistance in the breathing circuit.
Classification. Class II (performance standards).

Breathing circuit bacterial filter.

§868.5260
Breathing circuit bacterial filter.
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.
Classification. Class II (performance standards).

Breathing system heater.

§868.5270
Breathing system heater.
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.
Classification. Class II (performance standards).

Breathing tube support.

§868.5280
Breathing tube support.
Identification. A breathing tube support is a device that is intended to support and anchor a patient's breathing tube(s).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Carbon dioxide absorbent.

§868.5300
Carbon dioxide absorbent.
Identification. A carbon dioxide absorbent is a device intended for medical purposes that consists of an absorbent material (e.g., soda lime) that is intended to remove carbon dioxide from the gases in the breathing circuit.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Carbon dioxide absorber.

§868.5310
Carbon dioxide absorber.
Identification. A carbon dioxide absorber is a device that is intended for medical purposes and that is used in a breathing circuit as a container for carbon dioxide absorbent. It may include a canister and water drain.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Reservoir bag.

§868.5320
Reservoir bag.
Identification. A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Breathing gas mixer.

§868.5330
Breathing gas mixer.
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.
Classification. Class II (performance standards).

Nasal oxygen cannula.

§868.5340
Nasal oxygen cannula.
Identification. A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Nasal oxygen catheter.

§868.5350
Nasal oxygen catheter.
Identification. A nasal oxygen catheter is a device intended to be inserted through a patient's nostril to administer oxygen.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Posture chair for cardiac or pulmonary treatment.

§868.5365
Posture chair for cardiac or pulmonary treatment.
Identification. A posture chair for cardiac or pulmonary treatment is a device intended to assist in the rehabilitation and mobilization of patients with chronic heart or lung disease.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Heat and moisture condenser (artificial nose).

§868.5375
Heat and moisture condenser (artificial nose).
Identification. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Electroanesthesia apparatus.

§868.5400
Electroanesthesia apparatus.
Identification. An electroanesthesia apparatus is a device used for the induction and maintenance of anesthesia during surgical procedures by means of an alternating or pulsed electric current that is passed through electrodes fixed to a patient's head.
Classification. Class III (premarket approval).

Ether hook.

§868.5420
Ether hook.
Identification. An ether hook is a device that fits inside a patient's mouth and that is intended to deliver vaporized ether.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Gas-scavenging apparatus.

§868.5430
Gas-scavenging apparatus.
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.
Classification. Class II (performance standards).

Portable oxygen generator.

§868.5440
Portable oxygen generator.
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).
Classification. Class II (performance standards).

Respiratory gas humidifier.

§868.5450
Respiratory gas humidifier.
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.
Classification. Class II (performance standards).

Therapeutic humidifier for home use.

§868.5460
Therapeutic humidifier for home use.
Identification. A therapeutic humidifier for home use is a device that adds water vapor to breathing gases and that is intended for respiratory therapy or other medical purposes. The vapor produced by the device pervades the area surrounding the patient, who breathes the vapor during normal respiration.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Hyperbaric chamber.

§868.5470
Hyperbaric chamber.
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (878.5650).
Classification. Class II (performance standards).

Flexible laryngoscope.

§868.5530
Flexible laryngoscope.
Identification. A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Rigid laryngoscope.

§868.5540
Rigid laryngoscope.
Identification. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9

Anesthetic gas mask.

§868.5550
Anesthetic gas mask.
Identification. An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper airway.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Gas mask head strap.

§868.5560
Gas mask head strap.
Identification. A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Nonrebreathing mask.

§868.5570
Nonrebreathing mask.
Identification. A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Oxygen mask.

§868.5580
Oxygen mask.
Identification. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Scavenging mask.

§868.5590
Scavenging mask.
Identification. A scavenging mask is a device positioned over a patient's nose to deliver anesthetic or analgesic gases to the upper airway and to remove excess and exhaled gas. It is usually used during dentistry.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Venturi mask.

§868.5600
Venturi mask.
Identification. A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Breathing mouthpiece.

§868.5620
Breathing mouthpiece.
Identification. A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 868.9.

Nebulizer.

§868.5630
Nebulizer.
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.
Classification. Class II (performance standards).

Medicinal nonventilatory nebulizer (atomizer).

§868.5640
Medicinal nonventilatory nebulizer (atomizer).
Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 868.9.

Esophageal obturator.

§868.5650
Esophageal obturator.
Identification. An esophageal obturator is a device inserted through a patient's mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea. The device consists of a closed-end semirigid esophageal tube that is attached to a face mask.
Classification. Class II (performance standards).

Portable liquid oxygen unit.

§868.5655
Portable liquid oxygen unit.
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.
Classification. Class II (performance standards).

Powered percussor.

§868.5665
Powered percussor.
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.
Classification. Class II (performance standards).

Rebreathing device.

§868.5675
Rebreathing device.
Identification. A rebreathing device is a device that enables a patient to rebreathe exhaled gases. It may be used in conjunction with pulmonary function testing or for increasing minute ventilation.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 868.9.

Incentive spirometer.

§868.5690
Incentive spirometer.
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.
Classification. Class II (performance standards).

Nonpowered oxygen tent.

§868.5700
Nonpowered oxygen tent.
Identification. A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 868.9.

Electrically powered oxygen tent.

§868.5710
Electrically powered oxygen tent.
Identification. An electrically powered oxygen tent is a device that encloses a patient's head and, by means of an electrically powered unit, administers breathing oxygen and controls the temperature and humidity of the breathing gases. This generic type device includes the pediatric aerosol tent.
Classification. Class II (performance standards).

Bronchial tube.

§868.5720
Bronchial tube.
Identification. A bronchial tube is a device used to differentially intubate a patient's bronchus (one of the two main branches of the trachea leading directly to the lung) in order to isolate a portion of lung distal to the tube.
Classification. Class II (performance standards).

Tracheal tube.

§868.5730
Tracheal tube.
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
Classification. Class II (performance standards).

Tracheal/bronchial differential ventilation tube.

§868.5740
Tracheal/bronchial differential ventilation tube.
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.
Classification. Class II (performance standards).

Inflatable tracheal tube cuff.

§868.5750
Inflatable tracheal tube cuff.
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.
Classification. Class II (performance standards).

Cuff spreader.

§868.5760
Cuff spreader.
Identification. A cuff spreader is a device used to install tracheal tube cuffs on tracheal or tracheostomy tubes.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Tracheal tube fixation device.

§868.5770
Tracheal tube fixation device.
Identification. A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Tube introduction forceps.

§868.5780
Tube introduction forceps.
Identification. Tube introduction forceps (e.g., Magill forceps) are a right-angled device used to grasp a tracheal tube and place it in a patient's trachea.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Tracheal tube stylet.

§868.5790
Tracheal tube stylet.
Identification. A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Tracheal tube cleaning brush.

§868.5795
Tracheal tube cleaning brush.
Identification. A tracheal tube cleaning brush is a device consisting of a brush with plastic bristles intended to clean tracheal cannula devices after their removal from patients.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Tracheostomy tube and tube cuff.

§868.5800
Tracheostomy tube and tube cuff.
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.
Classification. Class II.

Airway connector.

§868.5810
Airway connector.
Identification. An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Dental protector.

§868.5820
Dental protector.
Identification. A dental protector is a device intended to protect a patient's teeth during manipulative procedures within a patient's oral cavity.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Autotransfusion apparatus.

§868.5830
Autotransfusion apparatus.
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.
Classification. Class II (performance standards).

Pressure tubing and accessories.

§868.5860
Pressure tubing and accessories.
Identification. Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Nonrebreathing valve.

§868.5870
Nonrebreathing valve.
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.
Classification. Class II (performance standards).

Anesthetic vaporizer.

§868.5880
Anesthetic vaporizer.
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
Classification. Class II (performance standards).

Continuous ventilator.

§868.5895
Continuous ventilator.
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
Classification. Class II (performance standards).

Noncontinuous ventilator (IPPB).

§868.5905
Noncontinuous ventilator (IPPB).
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.
Classification. Class II (performance standards).

Manual emergency ventilator.

§868.5915
Manual emergency ventilator.
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.
Classification. Class II (performance standards).

Powered emergency ventilator.

§868.5925
Powered emergency ventilator.
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.
Classification. Class II (performance standards).

External negative pressure ventilator.

§868.5935
External negative pressure ventilator.
Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.
Classification. Class II (performance standards).

Intermittent mandatory ventilation attachment.

§868.5955
Intermittent mandatory ventilation attachment.
Identification. An intermittent mandatory ventilation (IMV) attachment is a device attached to a mechanical ventilator that allows spontaneous breathing by a patient while providing mechanical ventilation at a preset rate.
Classification. Class II (performance standards).

Positive end expiratory pressure breathing attachment.

§868.5965
Positive end expiratory pressure breathing attachment.
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.
Classification. Class II (performance standards).

Ventilator tubing.

§868.5975
Ventilator tubing.
Identification. Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Tee drain (water trap).

§868.5995
Tee drain (water trap).
Identification. A tee drain (water trap) is a device intended to trap and drain water that collects in ventilator tubing during respiratory therapy, thereby preventing an increase in breathing resistance.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Additional Factors/Tools

Additional Factors/Tools

Anesthetic cabinet, table, or tray.

§868.6100
Anesthetic cabinet, table, or tray.
Identification. An anesthetic cabinet, table, or tray is a device intended to store anesthetic equipment and drugs. The device is usually constructed to eliminate build-up of static electrical charges.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Cardiopulmonary emergency cart.

§868.6175
Cardiopulmonary emergency cart.
Identification. A cardiopulmonary emergency cart is a device intended to store and transport resuscitation supplies for emergency treatment. The device does not include any equipment used in cardiopulmonary resuscitation.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Nose clip.

§868.6225
Nose clip.
Identification. A nose clip is a device intended to close a patient's external nares (nostrils) during diagnostic or therapeutic procedures.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Portable air compressor.

§868.6250
Portable air compressor.
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.
Classification. Class II (performance standards).

Calibration gas.

§868.6400
Calibration gas.
Identification. A calibration gas is a device consisting of a container of gas of known concentration intended to calibrate medical gas concentration measurement devices.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Anesthesia stool.

§868.6700
Anesthesia stool.
Identification. An anesthesia stool is a device intended for use as a stool for the anesthesiologist in the operating room.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Tracheobronchial suction catheter.

§868.6810
Tracheobronchial suction catheter.
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 868.9.

Patient position support.

§868.6820
Patient position support.
Identification. A patient position support is a device intended to maintain the position of an anesthetized patient during surgery.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Medical gas yoke assembly.

§868.6885
Medical gas yoke assembly.
Identification. A medical gas yoke assembly is a device intended to connect medical gas cylinders to regulators or needle valves to supply gases for anesthesia or respiratory therapy. The device may include a particulate filter.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.