FDA Medical Device Classes

Nearly 2,000 individual medical devices have been classified by the Food and Drug Administration. This separates medical devices into 16 distinct groups, also known as "panels." Examples of these panels include dental, neurology, orthopedic, radiology and more. After being put into one of these 16 panels, FDA-approved medical devices are further split into three specific classes: Class I, Class II and Class III. This allows both users of such devices and medical professionals to easily find important information about the devices they use.

Class I Devices

• Class I general hospital equipment includes bandages, bedpans, bedding, examination gowns, medical insoles, lubricants and more. Class I ear, nose and throat equipment includes applicators, balloons, clamps, tongue depressors, dilators, inhalers, irrigators, scissors, tubes and more. Class I physical medicine equipment includes wheelchair belts, lap boards, canes, cushions, helmets, massagers, scales, slings, splints, tables and more. Class I anesthesiology equipment includes reservoir bags, blow bottles, various calibrators, flowmeters, oxygen masks, oxygen tents and more. Class I dental equipment includes denture adhesive, x-ray machines, dentist chairs, clamps, cotton rolls, rubber dams, surgical hemostats, surgical headlights, syringes and more. Class I hematology equipment includes various types of acid, bottles, dishes and other various substances. Class I neurology equipment includes tuning forks, generators, various clips, skullplate screwdriver and more. Class I toxicology equipment includes blood alcohol test kits, drug test kits, drug-specific control materials and more.

Class II Devices

• Class II general hospital equipment includes hospital bassinets, beds, bottles, cabinets, containers, mattresses, syringes, tubing and more. Class II immunology equipment includes various antibodies, soluble cancer monitoring test systems, influenza, insulin, system tests and more. Class II general and plastic surgery equipment includes body fluid barrier kits, various clips, drapes, general surgery trays, patient gowns, surgical gowns, operating room lamps, prostheses, shave prep kits, staples, sutures, wound dressing and more. Class II orthopedic equipment includes bone cement, fasteners, pins, plates, prostheses, rods, screws, staples and more. Class II cardiovascular equipment includes blood pressure cuffs, various catheters, clamps, diagnostic computers, electrodes, transducers and more. Class II microbiology equipment includes various antigens, antiserums, enzymes, and test equipment. Class II neurology equipment includes catheters, monitoring devices, drills, electrodes, motors, stimulators and more. Class II physical medicine equipment includes baths, chairs, wheelchairs, wheelchair elevators, heating pads and more.

Class III Devices

• Class III cardiovascular equipment includes defibrillators, generators, pumps, stimulators and more. Class III orthopedic equipment includes heterograft bone, prostheses and more. Class III dental equipment includes denture adhesive, dental biologic material, resins, sterilizers and more.

Classification Guidelines

• Medical device are separated into Class I, Class II or Class III based on a variety of factors. Classifications are based on the amount of control needed to operate the device safely and effectively as well as the amount of risk involved to either the patient or the operator. These classifications are based on the intended usage of the medical device in question.