FDA medical devices classification list

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

    - Scope.
    - Effective dates of requirement for premarket approval.
    - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    - Manual algesimeter.
    - Powered algesimeter.
    - Argon gas analyzer.
    - Arterial blood sampling kit.
    - Indwelling blood oxyhemoglobin concentration analyzer.
    - Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.
    - Indwelling blood hydrogen ion concentration (pH) analyzer.
    - Indwelling blood oxygen partial pressure (PO2) analyzer.
    - Carbon dioxide gas analyzer.
    - Carbon monoxide gas analyzer.
    - Enflurane gas analyzer.
    - Ventilatory electrical impedance tomograph.
    - Gas collection vessel.
    - Halothane gas analyzer.
    - Helium gas analyzer.
    - Neon gas analyzer.
    - Nitrogen gas analyzer.
    - Nitrous oxide gas analyzer.
    - Oxygen gas analyzer.
    - Oxygen uptake computer.
    - Pressure plethysmograph.
    - Volume plethysmograph.
    - Inspiratory airway pressure meter.
    - Rhinoanemometer.
    - Diagnostic spirometer.
    - Monitoring spirometer.
    - Peak-flow meter for spirometry.
    - Gas volume calibrator.
    - Pulmonary-function data calculator.
    - Predictive pulmonary-function value calculator.
    - Diagnostic pulmonary-function interpretation calculator.
    - Esophageal stethoscope.
    - Esophageal stethoscope with electrical conductors.
    - Stethoscope head.
    - Switching valve (ploss).
    - Water vapor analyzer.

    - Ultrasonic air embolism monitor.
    - Bourdon gauge flowmeter.
    - Uncompensated thorpe tube flowmeter.
    - Compensated thorpe tube flowmeter.
    - Gas calibration flowmeter.
    - Breathing frequency monitor.
    - Apnea monitor.
    - Nitric oxide analyzer.
    - Nitrogen dioxide analyzer.
    - Lung water monitor.
    - Cutaneous carbon dioxide (PcCO2) monitor.
    - Cutaneous oxygen (PcO2) monitor.
    - Pneumotachometer.
    - Airway pressure monitor.
    - Gas pressure gauge.
    - Gas pressure calibrator.
    - Pressure regulator.
    - Electrical peripheral nerve stimulator.
    - Differential pressure transducer.
    - Gas flow transducer.
    - Gas pressure transducer.

Subparts D-E [Reserved]

    - Emergency airway needle.
    - Retrograde intubation device.
    - Nasopharyngeal airway.
    - External negative pressure airway aid.
    - Oropharyngeal airway.
    - Device to relieve acute upper airway obstruction.
    - Anesthesia conduction catheter.
    - Anesthesia conduction filter.
    - Anesthesia conduction kit.
    - Anesthesia conduction needle.
    - Gas machine for anesthesia or analgesia.
    - Nitric oxide administration apparatus.
    - Laryngotracheal topical anesthesia applicator.
    - Rocking bed.
    - Blow bottle.
    - Anesthesia breathing circuit.
    - Breathing circuit circulator.
    - Breathing circuit bacterial filter.
    - Breathing system heater.

    - Positive airway pressure delivery system.
    - Breathing tube support.
    - Carbon dioxide absorbent.
    - Carbon dioxide absorber.
    - Reservoir bag.
    - Breathing gas mixer.
    - Nasal oxygen cannula.
    - Nasal oxygen catheter.
    - Posture chair for cardiac or pulmonary treatment.
    - Heat and moisture condenser (artificial nose).
    - Electroanesthesia apparatus.
    - Ether hook.
    - Gas-scavenging apparatus.
    - Portable oxygen generator.
    - Respiratory gas humidifier.
    - High flow humidified oxygen delivery device.
    - Therapeutic humidifier for home use.
    - Hyperbaric chamber.
    - Isocapnic ventilation device.
    - Flexible laryngoscope.
    - Rigid laryngoscope.
    - Anesthetic gas mask.
    - Gas mask head strap.
    - Nonrebreathing mask.
    - Oxygen mask.
    - Scavenging mask.
    - Venturi mask.
    - Breathing mouthpiece.
    - Nebulizer.
    - Medicinal nonventilatory nebulizer (atomizer).
    - Esophageal obturator.
    - Portable liquid oxygen unit.
    - Powered percussor.
    - Rebreathing device.
    - Incentive spirometer.
    - Nonpowered oxygen tent.
    - Electrically powered oxygen tent.
    - Bronchial tube.
    - Tracheal tube.
    - Tracheal/bronchial differential ventilation tube.
    - Inflatable tracheal tube cuff.
    - Cuff spreader.
    - Tracheal tube fixation device.
    - Tube introduction forceps.

    - Tracheal tube stylet.
    - Tracheal tube cleaning brush.
    - Tracheostomy tube and tube cuff.
    - Airway connector.
    - Dental protector.
    - Autotransfusion apparatus.
    - Pressure tubing and accessories.
    - Nonrebreathing valve.
    - Anesthetic vaporizer.
    - Continuous ventilator.
    - Noncontinuous ventilator (IPPB).
    - Manual emergency ventilator.
    - Powered emergency ventilator.
    - External negative pressure ventilator.
    - Intermittent mandatory ventilation attachment.
    - Positive end expiratory pressure breathing attachment.
    - Ventilator tubing.
    - Tee drain (water trap).

    - Anesthetic cabinet, table, or tray.
    - Cardiopulmonary emergency cart.
    - Nose clip.
    - Portable air compressor.
    - Calibration gas.
    - Anesthesia stool.
    - Tracheobronchial suction catheter.
    - Patient position support.
    - Medical gas yoke assembly.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 47 FR 31142, July 16, 1982, unless otherwise noted.

Extracted from US. FDA