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 |
|---|---|---|---|---|---|
| FJN | Stabilizer, Shunt | Class II | 21 CFR 876.5540 | 0 | 0 |
| FJO | Plier, Tube | Class I | 21 CFR 876.5540 | 0 | 0 |
| FJP | Adaptor, Y | Class II | 21 CFR 876.5820 | 0 | 1 |
| FJQ | Connector, Shunt | Class I | 21 CFR 876.5540 | 3 | 0 |
| FJR | Forceps, Disconnect | Class I | 21 CFR 876.5540 | 0 | 0 |
| FJS | Catheter, Peritoneal, Long-Term Indwelling | Class II | 21 CFR 876.5630 | 48 | 8 |
| FJT | Intracatheter, Dialysis | Class II | 21 CFR 876.5820 | 5 | 0 |
| FJW | Ring, Joint | Class I | 21 CFR 876.5540 | 0 | 0 |
| FJX | Ring, Crimp | Class I | 21 CFR 876.5540 | 0 | 0 |
| FJY | Plier, Crimp | Class I | 21 CFR 876.5540 | 0 | 0 |
| FJZ | Declotting Tray, Kit (Including Contents) | Class II | 21 CFR 876.5820 | 3 | 0 |
| FKA | Dilator, Vessel | Class II | 21 CFR 876.5540 | 3 | 0 |
| FKB | Connector, Blood Tubing, Infusion T | Class II | 21 CFR 876.5820 | 2 | 1 |
| FKC | Clamp, Cannula | Class I | 21 CFR 876.5540 | 1 | 0 |
| FKD | Canister, Coil | Class II | 21 CFR 876.5820 | 1 | 0 |
| FKE | Tie, Dialysis | Class I | 21 CFR 876.5820 | 0 | 0 |
| FKF | Gun, Tie, Dialysis | Class I | 21 CFR 876.5820 | 0 | 0 |
| FKG | Tray, Start/Stop (Including Contents), Dialysis | Class I | 21 CFR 876.5820 | 6 | 11 |
| FKH | Solution-Test Standard-Conductivity, Dialysis | Class II | 21 CFR 876.5820 | 8 | 2 |
| FKI | Set, Dialyzer Holder | Class II | 21 CFR 876.5820 | 3 | 0 |
| FKJ | Filter, Blood, Dialysis | Class II | 21 CFR 876.5820 | 5 | 0 |
| FKK | Clamp, Line | Class I | 21 CFR 876.4730 | 6 | 0 |
| FKL | Insert, Pump, Blood | Class II | 21 CFR 876.5820 | 1 | 0 |
| FKM | Adaptor, Fistula | Class II | 21 CFR 876.5820 | 0 | 0 |
| FKN | Adaptor, Shunt | Class II | 21 CFR 876.5540 | 4 | 0 |
| FKO | Catheter, Peritoneal Dialysis, Single Use | Class II | 21 CFR 876.5630 | 16 | 0 |
| FKP | System, Dialysate Delivery, Single Patient | Class II | 21 CFR 876.5820 | 50 | 12 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | Class II | 21 CFR 876.5820 | 61 | 2 |
| FKR | Subsystem, Proportioning | Class II | 21 CFR 876.5820 | 12 | 10 |
| FKT | System, Dialysate Delivery, Sorbent Regenerated | Class II | 21 CFR 876.5600 | 19 | 0 |
| FKW | Tip, Vessel | Class II | 21 CFR 876.5540 | 3 | 0 |
| FKX | System, Peritoneal, Automatic Delivery | Class II | 21 CFR 876.5630 | 83 | 51 |
| FKY | Connector, Tubing, Dialysate | Class II | 21 CFR 876.5820 | 4 | 0 |
| FLA | Monitor, Temperature, Dialysis | Class II | 21 CFR 876.5820 | 3 | 0 |
| FLB | Meter, Conductivity, Induction, Remote Type | Class II | 21 CFR 876.5820 | 6 | 0 |
| FLC | Station, Dialysis Control, Negative Pressure Type | Class II | 21 CFR 876.5820 | 4 | 0 |
| FLD | Apparatus, Hemoperfusion, Sorbent | Class II | 21 CFR 876.5870 | 11 | 7 |
| FLE | Sterilizer, Steam | Class II | 21 CFR 880.6880 | 185 | 18 |
| FLF | Sterilizer, Ethylene-Oxide Gas | Class II | 21 CFR 880.6860 | 26 | 8 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | Class I | 21 CFR 880.6150 | 19 | 7 |
| FLH | Washer Of Body Waste Receptacles | Class I | 21 CFR 880.6800 | 0 | 0 |
| FLI | Cabinet, Ethylene-Oxide Gas Aerator | Class II | 21 CFR 880.6100 | 8 | 0 |
| FLJ | Unit, Airflow, Laminar | Class II | 21 CFR 878.5070 | 0 | 0 |
| FLK | Thermometer, Clinical Mercury | Class II | 21 CFR 880.2920 | 33 | 0 |
| FLL | Continuous Measurement Thermometer | Class II | 21 CFR 880.2910 | 798 | 19 |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | Class II | 21 CFR 880.2420 | 39 | 0 |
| FLS | Monitor, Apnea, Facility Use | Class II | 21 CFR 868.2377 | 16 | 2 |
| FMA | Depressor, Tongue, Non-Surgical | Class I | 21 CFR 880.6230 | 5 | 0 |
| FMC | Patient Examination Glove | Class I | 21 CFR 880.6250 | 34 | 0 |
| FME | Gown, Examination | Class I | 21 CFR 880.6265 | 5 | 1 |
| FMF | Syringe, Piston | Class II | 21 CFR 880.5860 | 752 | 305 |
| FMG | Stopcock, I.V. Set | Class II | 21 CFR 880.5440 | 89 | 207 |
| FMH | Container, Specimen, Sterile | Class I | 21 CFR 864.3250 | 23 | 21 |
| FMI | Needle, Hypodermic, Single Lumen | Class II | 21 CFR 880.5570 | 694 | 311 |
| FMJ | Manometer, Spinal-Fluid | Class II | 21 CFR 880.2500 | 6 | 5 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class II | 21 CFR 878.4850 | 111 | 17 |
| FML | Chair, Blood Donor | Class I | 21 CFR 880.6140 | 2 | 0 |
| FMP | Protector, Skin Pressure | Class I | 21 CFR 880.6450 | 23 | 4 |
| FMQ | Restraint, Protective | Class I | 21 CFR 880.6760 | 134 | 33 |
| FMR | Device, Transfer, Patient, Manual | Class I | 21 CFR 880.6785 | 5 | 0 |
| FMS | Bed, Pediatric Open Hospital | Class II | 21 CFR 880.5140 | 27 | 5 |
| FMT | Warmer, Infant Radiant | Class II | 21 CFR 880.5130 | 92 | 36 |
| FMW | Cover, Mattress (Medical Purposes) | Class I | 21 CFR 880.6190 | 14 | 3 |
| FMZ | Incubator, Neonatal | Class II | 21 CFR 880.5400 | 86 | 43 |
| FNC | Tent, Pediatric Aerosol | Class II | 21 CFR 868.5710 | 1 | 0 |
| FNG | Lift, Patient, Ac-Powered | Class II | 21 CFR 880.5500 | 21 | 23 |
| FNJ | Bed, Manual | Class I | 21 CFR 880.5120 | 39 | 7 |
| FNK | Bed, Hydraulic, Adjustable Hospital | Class I | 21 CFR 880.5110 | 1 | 4 |
| FNL | Bed, Ac-Powered Adjustable Hospital | Class II | 21 CFR 880.5100 | 70 | 155 |
| FNM | Mattress, Air Flotation, Alternating Pressure | Class II | 21 CFR 880.5550 | 102 | 13 |
| FNN | Nipple, Lambs Feeding | Class I | 21 CFR 880.5640 | 0 | 0 |
| FNP | Urinal | Class I | 21 CFR 880.6730 | 1 | 0 |
| FNS | Ring Cutter | Class I | 21 CFR 880.6200 | 0 | 0 |
| FNW | Pad, Kelly | Class II | 21 CFR 878.4370 | 2 | 0 |
| FNY | Basin, Emesis | Class I | 21 CFR 880.6730 | 9 | 1 |
| FOA | Board, Cardiopulmonary | Class I | 21 CFR 880.6080 | 3 | 0 |
| FOB | Bedpan | Class I | 21 CFR 880.6730 | 5 | 0 |
| FOC | Bag, Urine Collection, Newborn | Class II | 21 CFR 876.5250 | 4 | 0 |
| FOD | Device, Occlusion, Umbilical | Class I | 21 CFR 880.5950 | 0 | 0 |
| FOG | Hood, Oxygen, Infant | Class I | 21 CFR 868.5700 | 9 | 0 |
| FOH | Mattress, Water, Temperature Regulated | Class I | 21 CFR 880.5560 | 6 | 0 |
| FOK | Pad, Neonatal Eye | Class I | 21 CFR 880.5270 | 5 | 0 |
| FON | Bag, Drainage, With Adhesive, Ostomy | Class I | 21 CFR 876.5900 | 3 | 5 |
| FOS | Catheter, Umbilical Artery | Class II | 21 CFR 880.5200 | 34 | 7 |
| FOX | Stand, Infusion | Class I | 21 CFR 880.6990 | 36 | 5 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class II | 21 CFR 880.5200 | 508 | 394 |
| FPA | Set, Administration, Intravascular | Class II | 21 CFR 880.5440 | 1,175 | 1,089 |
| FPB | Filter, Infusion Line | Class II | 21 CFR 880.5440 | 99 | 8 |
| FPD | Tube, Feeding | Class II | 21 CFR 876.5980 | 59 | 24 |
| FPF | Bottle, Hot/Cold Water | Class I | 21 CFR 880.6085 | 1 | 0 |
| FPK | Tubing, Fluid Delivery | Class II | 21 CFR 880.5440 | 64 | 28 |
| FPL | Incubator, Neonatal Transport | Class II | 21 CFR 880.5410 | 25 | 1 |
| FPO | Stretcher, Wheeled | Class II | 21 CFR 880.6910 | 50 | 76 |
| FPP | Stretcher, Hand-Carried | Class I | 21 CFR 880.6900 | 39 | 12 |
| FPS | Board, Bed | Class I | 21 CFR 880.6070 | 1 | 4 |
| FPX | Strip, Adhesive, Closure, Skin | Class I | 21 CFR 880.5240 | 35 | 1 |
| FPY | Sheet, Burn | Class I | 21 CFR 880.5180 | 17 | 1 |
| FQA | Scale, Surgical Sponge | Class I | 21 CFR 880.2740 | 1 | 1 |
| FQH | Lavage, Jet | Class II | 21 CFR 880.5475 | 53 | 29 |
| FQJ | Support, Scrotal, Therapeutic | Class I | 21 CFR 880.5820 | 0 | 0 |
