FDA product codes
The device classification tree, in product code order.
FDA classifies every device type under a three-letter product code, and that code is what ties a clearance to a recall to a registered listing. Each page here carries the FDA definition, the regulation it sits under, clearance volume by year, and the companies that list the code with FDA.
Data as of , the FDA export date. FDA product classification database
Review panels
6,880 codes| Review panel | Panel code | Product codes |
|---|---|---|
| Anesthesiology | AN | 262 |
| Cardiovascular | CV | 437 |
| Clinical Chemistry | CH | 527 |
| Clinical Toxicology | TX | 338 |
| Dental | DE | 352 |
| Ear, Nose, Throat | EN | 269 |
| Gastroenterology, Urology | GU | 614 |
| General Hospital | HO | 394 |
| General, Plastic Surgery | SU | 562 |
| Hematology | HE | 281 |
| Immunology | IM | 278 |
| Medical Genetics | MG | 7 |
| Microbiology | MI | 554 |
| Neurology | NE | 291 |
| Obstetrics/Gynecology | OB | 269 |
| Ophthalmic | OP | 345 |
| Orthopedic | OR | 349 |
| Pathology | PA | 325 |
| Physical Medicine | PM | 210 |
| Radiology | RA | 216 |
| Code | Device name | Class | Regulation | Clearances | Recalls |
|---|---|---|---|---|---|
| IFS | Solution, Helly | Class I | 21 CFR 864.4010 | 0 | 0 |
| IFT | Glutaraldehyde | Class I | 21 CFR 864.4010 | 1 | 0 |
| IFY | Gelatin-Formalin | Class I | 21 CFR 864.4010 | 0 | 0 |
| IFZ | Gelatin For Specimen Adhesion | Class I | 21 CFR 864.4010 | 1 | 0 |
| IGB | Solution, Formalin-Sodium Acetate | Class I | 21 CFR 864.4010 | 1 | 0 |
| IGC | Formalin-Saline | Class I | 21 CFR 864.4010 | 2 | 0 |
| IGD | Solution, Formol Calcium | Class I | 21 CFR 864.4010 | 0 | 0 |
| IGE | Solution, Formalin Ammonium Bromide | Class I | 21 CFR 864.4010 | 2 | 0 |
| IGF | Solution, Formalin-Alcohol-Acetic Acid | Class I | 21 CFR 864.4010 | 1 | 0 |
| IGG | Formaldehyde (Formalin, Formol) | Class I | 21 CFR 864.4010 | 7 | 1 |
| IGK | Solution, Clarke'S | Class I | 21 CFR 864.4010 | 0 | 0 |
| IGM | Solution, Carnoy'S | Class I | 21 CFR 864.4010 | 3 | 0 |
| IGN | Fluid, Bouin'S | Class I | 21 CFR 864.4010 | 2 | 0 |
| IHJ | Blender, Sputum | Class I | 21 CFR 864.3010 | 0 | 0 |
| IJZ | Oil, Clearing | Class I | 21 CFR 864.4010 | 1 | 0 |
| IKD | Cable, Electrode | Class II | 21 CFR 890.1175 | 6 | 11 |
| IKE | Transducer, Miniature Pressure | Class I | 21 CFR 890.1615 | 15 | 0 |
| IKK | System, Isokinetic Testing And Evaluation | Class II | 21 CFR 890.1925 | 61 | 4 |
| IKN | Electromyograph, Diagnostic | Class II | 21 CFR 890.1375 | 75 | 1 |
| IKO | Hammer, Reflex, Powered | Class II | 21 CFR 890.1450 | 1 | 0 |
| IKP | Chronaximeter | Class II | 21 CFR 890.1225 | 0 | 0 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | Class II | 21 CFR 890.1385 | 43 | 2 |
| IKW | Utensil, Homemaking | Class I | 21 CFR 890.5050 | 12 | 0 |
| IKX | Aid, Transfer | Class I | 21 CFR 890.5050 | 18 | 20 |
| IKY | Mattress, Flotation Therapy, Non-Powered | Class I | 21 CFR 880.5150 | 8 | 11 |
| IKZ | Bed, Patient Rotation, Powered | Class II | 21 CFR 890.5225 | 17 | 12 |
| ILC | Utensil, Eating | Class I | 21 CFR 890.5050 | 32 | 0 |
| ILD | Adaptor, Dressing | Class I | 21 CFR 890.5050 | 14 | 0 |
| ILE | Sling, Arm, Overhead Supported | Class I | 21 CFR 890.3475 | 3 | 0 |
| ILG | Stocking, Elastic | Class I | 21 CFR 890.3475 | 8 | 3 |
| ILH | Splint, Hand, And Components | Class I | 21 CFR 890.3475 | 36 | 1 |
| ILI | Sling, Arm | Class I | 21 CFR 890.3640 | 21 | 5 |
| ILJ | Bath, Hydro-Massage | Class II | 21 CFR 890.5100 | 73 | 10 |
| ILK | Transport, Patient, Powered | Class II | 21 CFR 890.5150 | 36 | 7 |
| ILM | Bath, Sitz, Powered | Class II | 21 CFR 890.5100 | 2 | 0 |
| ILO | Pack, Hot Or Cold, Water Circulating | Class II | 21 CFR 890.5720 | 93 | 22 |
| ILP | System, Communication, Non-Powered | Class I | 21 CFR 890.3700 | 21 | 0 |
| ILQ | System, Communication, Powered | Class II | 21 CFR 890.3710 | 38 | 19 |
| ILS | Adaptor, Hygiene | Class I | 21 CFR 890.5050 | 31 | 4 |
| ILT | Adaptor, Recreational | Class I | 21 CFR 890.5050 | 7 | 0 |
| ILW | Adaptor, Grooming | Class I | 21 CFR 890.5050 | 7 | 0 |
| ILX | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | Class II | 21 CFR 890.5290 | 15 | 1 |
| ILY | Lamp, Infrared, Therapeutic Heating | Class II | 21 CFR 890.5500 | 229 | 20 |
| ILZ | Accessories, Traction | Class I | 21 CFR 890.5925 | 15 | 0 |
| IMA | Pack, Heat, Moist | Class I | 21 CFR 890.5730 | 8 | 9 |
| IMB | Cabinet, Moist Steam | Class II | 21 CFR 890.5250 | 5 | 5 |
| IMC | Bath, Paraffin | Class II | 21 CFR 890.5110 | 12 | 0 |
| IMD | Pack, Hot Or Cold, Disposable | Class I | 21 CFR 890.5710 | 82 | 26 |
| IME | Pack, Hot Or Cold, Reusable | Class I | 21 CFR 890.5700 | 27 | 12 |
| IMF | Unit, Chilling | Class I | 21 CFR 890.5940 | 2 | 1 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | Class II | 21 CFR 890.5860 | 55 | 2 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | Class II | 21 CFR 890.5300 | 89 | 3 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | Class II | 21 CFR 890.5290 | 45 | 1 |
| IMK | Wheelchair, Stair Climbing | Class II | 21 CFR 890.3890 | 3 | 4 |
| IML | Armrest, Wheelchair | Class I | 21 CFR 890.3920 | 0 | 0 |
| IMM | Footrest, Wheelchair | Class I | 21 CFR 890.3920 | 2 | 0 |
| IMN | Climber, Curb, Wheelchair | Class I | 21 CFR 890.3920 | 0 | 0 |
| IMO | Handrim, Wheelchair | Class I | 21 CFR 890.3920 | 0 | 0 |
| IMP | Cushion, Wheelchair | Class I | 21 CFR 890.3920 | 2 | 1 |
| IMQ | Attachment, Narrowing, Wheelchair | Class I | 21 CFR 890.3920 | 0 | 0 |
| IMR | Device, Anti-Tip, Wheelchair | Class I | 21 CFR 890.3920 | 0 | 0 |
| IMS | Support, Head And Trunk, Wheelchair | Class I | 21 CFR 890.3910 | 0 | 1 |
| IMW | Brake, Extension, Wheelchair | Class I | 21 CFR 890.3920 | 0 | 0 |
| IMX | Board, Lap, Wheelchair | Class I | 21 CFR 890.3910 | 2 | 0 |
| IMY | Armboard, Wheelchair | Class I | 21 CFR 890.3910 | 0 | 0 |
| IMZ | Holder, Crutch And Cane, Wheelchair | Class I | 21 CFR 890.3910 | 0 | 0 |
| INA | Hill Holder, Wheelchair | Class I | 21 CFR 890.3920 | 0 | 0 |
| INB | Attachment, Commode, Wheelchair | Class I | 21 CFR 890.3920 | 0 | 0 |
| INC | Cuff, Pusher, Wheelchair | Class I | 21 CFR 890.3910 | 0 | 0 |
| INE | Sling, Overhead Suspension, Wheelchair | Class I | 21 CFR 890.3910 | 1 | 0 |
| INF | Scale, Platform, Wheelchair | Class I | 21 CFR 890.3940 | 5 | 0 |
| ING | Elevator, Wheelchair, Portable | Class II | 21 CFR 890.3930 | 29 | 3 |
| INI | Vehicle, Motorized 3-Wheeled | Class II | 21 CFR 890.3800 | 353 | 22 |
| INK | Stretcher, Wheeled, Powered | Class II | 21 CFR 890.3690 | 12 | 16 |
| INM | Chair, With Casters | Class I | 21 CFR 890.3100 | 35 | 25 |
| INN | Chair, Adjustable, Mechanical | Class I | 21 CFR 890.3100 | 26 | 23 |
| INO | Chair, Positioning, Electric | Class II | 21 CFR 890.3110 | 53 | 5 |
| INP | Tips And Pads, Cane, Crutch And Walker | Class I | 21 CFR 890.3790 | 8 | 9 |
| INQ | Table, Powered | Class I | 21 CFR 890.3760 | 102 | 2 |
| INT | Plinth | Class I | 21 CFR 890.3520 | 4 | 5 |
| INW | Table, Mechanical | Class I | 21 CFR 890.3750 | 35 | 1 |
| INX | Bed, Air Fluidized | Class II | 21 CFR 890.5160 | 28 | 9 |
| INY | Bed, Patient Rotation, Manual | Class I | 21 CFR 890.5180 | 1 | 0 |
| IOA | Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat | Class II | 21 CFR 890.5275 | 4 | 0 |
| IOB | Lamp, Infrared, Non Heating | Class II | 21 CFR 890.5500 | 6 | 0 |
| IOD | Components, Exercise | Class I | 21 CFR 890.5350 | 11 | 0 |
| IOE | Bars, Parallel, Exercise | Class I | 21 CFR 890.5370 | 2 | 0 |
| IOG | Treadmill, Mechanical | Class I | 21 CFR 890.5370 | 3 | 0 |
| IOL | Treadmill, Powered | Class I | 21 CFR 890.5380 | 43 | 19 |
| ION | Exerciser, Non-Measuring | Class I | 21 CFR 890.5370 | 43 | 2 |
| IOQ | Bed, Flotation Therapy, Powered | Class II | 21 CFR 890.5170 | 57 | 38 |
| IOR | Wheelchair, Mechanical | Class I | 21 CFR 890.3850 | 468 | 40 |
| IOY | Support, Arm | Class I | 21 CFR 890.3475 | 1 | 0 |
| IOZ | Splint, Abduction, Congenital Hip Dislocation | Class I | 21 CFR 890.3665 | 4 | 0 |
| IPF | Stimulator, Muscle, Powered | Class II | 21 CFR 890.5850 | 548 | 7 |
| IPG | Shoe, Cast | Class I | 21 CFR 890.3025 | 6 | 0 |
| IPL | Wheelchair, Standup | Class II | 21 CFR 890.3900 | 66 | 1 |
| IPM | Cover, Limb | Class I | 21 CFR 890.3025 | 6 | 1 |
| IPO | Orthosis, Pneumatic Structure, Rigid | Class III | 21 CFR 890.3610 | 0 | 0 |
| IPR | Crutch | Class I | 21 CFR 890.3150 | 4 | 5 |
