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).

    - Arrhythmia detector and alarm (including ST-segment measurement and alarm).
    - Blood pressure alarm.
    - Blood pressure computer.
    - Blood pressure cuff.
    - Noninvasive blood pressure measurement system.
    - Venous blood pressure manometer.
    - Diagnostic intravascular catheter.
    - Continuous flush catheter.
    - Electrode recording catheter or electrode recording probe.
    - Fiberoptic oximeter catheter.
    - Flow-directed catheter.
    - Percutaneous catheter.
    - Temporary catheter for embolic protection during transcatheter intracardiac procedures.
    - Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access.
    - Balloon aortic valvuloplasty catheter.
    - Intracavitary phonocatheter system.
    - Steerable catheter.
    - Steerable catheter control system.
    - Catheter cannula.
    - Vessel dilator for percutaneous catheterization.
    - Catheter guide wire.
    - Catheter introducer.
    - Catheter balloon repair kit.
    - Trace microsphere.
    - Catheter tip occluder.
    - Catheter stylet.
    - Trocar.
    - Coronary vascular physiologic simulation software device.
    - Programmable diagnostic computer.
    - Single-function, preprogrammed diagnostic computer.
    - Densitometer.
    - Angiographic injector and syringe.
    - Indicator injector.
    - Syringe actuator for an injector.
    - External programmable pacemaker pulse generator.
    - Withdrawal-infusion pump.

    - Stethoscope.
    - Thermodilution probe.

    - Biopotential amplifier and signal conditioner.
    - Transducer signal amplifier and conditioner.
    - Cardiovascular blood flowmeter.
    - Extravascular blood flow probe.
    - Adjunctive cardiovascular status indicator.
    - Adjunctive predictive cardiovascular indicator.
    - Cardiac monitor (including cardiotachometer and rate alarm).
    - Apex cardiograph (vibrocardiograph).
    - Ballistocardiograph.
    - Echocardiograph.
    - Electrocardiograph.
    - Electrocardiograph software for over-the-counter use.
    - Electrocardiograph lead switching adaptor.
    - Electrocardiograph electrode.
    - Electrocardiograph surface electrode tester.
    - Phonocardiograph.
    - Vectorcardiograph.
    - Medical cathode-ray tube display.
    - Signal isolation system.
    - Line isolation monitor.
    - Portable leakage current alarm.
    - Oscillometer.
    - Oximeter.
    - Ear oximeter.
    - Impedance phlebograph.
    - Impedance plethysmograph.
    - Hydraulic, pneumatic, or photoelectric plethysmographs.
    - Photoplethysmograph analysis software for over-the-counter use.
    - Medical magnetic tape recorder.
    - Paper chart recorder.
    - Apex cardiographic transducer.
    - Extravascular blood pressure transducer.
    - Implantable Intra-aneurysm Pressure Measurement System.
    - Heart sound transducer.
    - Catheter tip pressure transducer.
    - Ultrasonic transducer.
    - Vessel occlusion transducer.
    - Patient transducer and electrode cable (including connector).
    - Radiofrequency physiological signal transmitter and receiver.
    - Telephone electrocardiograph transmitter and receiver.

    - Vascular clip.
    - Vena cava clip.
    - Vascular embolization device.
    - Cardiovascular intravascular filter.
    - Vascular graft prosthesis.
    - Endovascular Suturing System.
    - Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
    - Intra-aortic balloon and control system.
    - Ventricular bypass (assist) device.
    - External pacemaker pulse generator.
    - Pacing system analyzer.
    - Implantable pacemaker pulse generator.
    - Pacemaker lead adaptor.
    - Pacemaker generator function analyzer.
    - Indirect pacemaker generator function analyzer.
    - Pacemaker polymeric mesh bag.
    - Pacemaker charger.
    - Cardiovascular permanent or temporary pacemaker electrode.
    - Pacemaker test magnet.
    - Pacemaker programmers.
    - Pacemaker repair or replacement material.
    - Pacemaker electrode function tester.
    - Pacemaker service tools.
    - Annuloplasty ring.
    - Carotid sinus nerve stimulator.
    - Replacement heart valve.
    - Prosthetic heart valve holder.
    - Prosthetic heart valve sizer.

    - Endomyocardial biopsy device.
    - Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
    - Cardiopulmonary bypass accessory equipment.
    - Cardiopulmonary bypass bubble detector.
    - Cardiopulmonary bypass vascular catheter, cannula, or tubing.
    - Cardiopulmonary bypass heart-lung machine console.
    - Cardiopulmonary bypass defoamer.
    - Cardiopulmonary bypass heat exchanger.
    - Cardiopulmonary bypass temperature controller.
    - Cardiopulmonary bypass arterial line blood filter.
    - Cardiopulmonary bypass cardiotomy suction line blood filter.
    - Cardiopulmonary prebypass filter.

    - Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
    - Cardiopulmonary bypass gas control unit.
    - Cardiopulmonary bypass coronary pressure gauge.
    - Cardiopulmonary bypass pulsatile flow generator.
    - Cardiopulmonary bypass on-line blood gas monitor.
    - Cardiopulmonary bypass level sensing monitor and/or control.
    - Cardiopulmonary bypass oxygenator.
    - Nonroller-type blood pump.
    - Roller-type cardiopulmonary bypass blood pump.
    - Cardiopulmonary bypass pump speed control.
    - Cardiopulmonary bypass pump tubing.
    - Cardiopulmonary bypass blood reservoir.
    - Cardiopulmonary bypass in-line blood gas sensor.
    - Cardiopulmonary bypass cardiotomy return sucker.
    - Cardiopulmonary bypass intracardiac suction control.
    - Vascular clamp.
    - Surgical vessel dilator.
    - Cardiovascular surgical instruments.
    - Apical closure device.
    - Intraluminal artery stripper.
    - External vein stripper.

    - Patient care suction apparatus.
    - Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
    - Embolectomy catheter.
    - Septostomy catheter.
    - External cardiac compressor.
    - Cardiopulmonary resuscitation (CPR) aid.
    - External counter-pulsating device.
    - DC-defibrillator (including paddles).
    - Automated external defibrillator system.
    - Defibrillator tester.
    - External transcutaneous cardiac pacemaker (noninvasive).
    - Steerable cardiac ablation catheter remote control system.
    - Compressible limb sleeve.
    - Thermal regulating system.
    - Esophageal thermal regulation device.
    - Automatic rotating tourniquet.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

Extracted from US.FDA