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 |
|---|---|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | Class I | 21 CFR 866.2390 | 111 | 18 |
| JSN | Culture Media, Propagating Transport | Class I | 21 CFR 866.2390 | 13 | 0 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | Class II | 21 CFR 866.1700 | 40 | 56 |
| JSP | Kit, Anaerobic Identification | Class I | 21 CFR 866.2660 | 18 | 2 |
| JSQ | Chromatography For Bacterial Identification | Class I | 21 CFR 862.2250 | 3 | 0 |
| JSR | Kit, Identification, Dermatophyte | Class I | 21 CFR 866.2660 | 1 | 0 |
| JSS | Kit, Identification, Enterobacteriaceae | Class I | 21 CFR 866.2660 | 49 | 9 |
| JST | Kit, Fastidious Organisms | Class I | 21 CFR 866.2660 | 6 | 6 |
| JSW | Kit, Identification, Glucose Nonfermenter | Class I | 21 CFR 866.2660 | 6 | 0 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | Class I | 21 CFR 866.2660 | 16 | 1 |
| JSY | Kit, Identification, Mycobacteria | Class I | 21 CFR 866.2660 | 5 | 1 |
| JSZ | Kit, Identification, Pseudomonas | Class I | 21 CFR 866.2660 | 1 | 0 |
| JTA | Monitor, Microbial Growth | Class I | 21 CFR 866.2560 | 11 | 0 |
| JTB | Device, Media Dispensing/Stacking | Class I | 21 CFR 866.2440 | 2 | 0 |
| JTC | Device, Microtiter Diluting/Dispensing | Class I | 21 CFR 866.2500 | 66 | 9 |
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | Class I | 21 CFR 866.2160 | 12 | 0 |
| JTM | Anaerobic Box Glove | Class I | 21 CFR 866.2120 | 1 | 0 |
| JTN | Susceptibility Test Discs, Antimicrobial | Class II | 21 CFR 866.1620 | 331 | 47 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | Class I | 21 CFR 866.2660 | 244 | 21 |
| JTQ | Bath, Incubators/Water, All | Class I | 21 CFR 866.2540 | 12 | 11 |
| JTR | Kit, Quality Control For Culture Media | Class I | 21 CFR 866.2480 | 12 | 46 |
| JTS | Stains, Microbiologic | Class I | 21 CFR 864.1850 | 40 | 9 |
| JTT | Susceptibility Test Powders, Antimicrobial | Class II | 21 CFR 866.1640 | 14 | 1 |
| JTW | System, Transport, Aerobic | Class I | 21 CFR 866.2900 | 43 | 8 |
| JTX | Transport Systems, Anaerobic | Class I | 21 CFR 866.2900 | 8 | 0 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | Class II | 21 CFR 866.2410 | 83 | 9 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | Class II | 21 CFR 866.1700 | 75 | 8 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | 21 CFR 888.3560 | 921 | 984 |
| JWI | Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained | Class II | 21 CFR 888.3800 | 3 | 0 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | Class II | 21 CFR 888.3800 | 17 | 0 |
| JWK | Antigen, Positive Control, Cryptococcus Neoformans | Class II | 21 CFR 866.3165 | 1 | 0 |
| JWL | Antigen, Treponema Pallidum For Fta-Abs Test | Class II | 21 CFR 866.3830 | 4 | 0 |
| JWM | System, Tomographic, Nuclear | Class II | 21 CFR 892.1310 | 17 | 1 |
| JWO | Device, Blood Volume Measuring | Class II | 21 CFR 864.5950 | 3 | 0 |
| JWR | Atp Release (Luminescence) | Class I | 21 CFR 864.7040 | 0 | 0 |
| JWT | Antigen, Cf, Aspergillus Spp. | Class I | 21 CFR 866.3040 | 5 | 0 |
| JWW | Antigen, Cf, B. Dermatitidis | Class II | 21 CFR 866.3060 | 3 | 0 |
| JWX | Kit, Screening, Staphylococcus Aureus | Class I | 21 CFR 866.2660 | 20 | 7 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | Class II | 21 CFR 866.1640 | 441 | 78 |
| JWZ | Kit, Screening, Trichomonas | Class I | 21 CFR 866.2660 | 11 | 1 |
| JXA | Kit, Screening, Urine | Class I | 21 CFR 866.2660 | 44 | 0 |
| JXB | Kit, Identification, Yeast | Class I | 21 CFR 866.2660 | 16 | 6 |
| JXC | Kit, Screening, Yeast | Class I | 21 CFR 866.2660 | 6 | 0 |
| JXE | Device, Nerve Conduction Velocity Measurement | Class II | 21 CFR 882.1550 | 27 | 1 |
| JXF | Plethysmograph, Ocular | Class III | 21 CFR 882.1790 | 0 | 0 |
| JXG | Shunt, Central Nervous System And Components | Class II | 21 CFR 882.5550 | 259 | 108 |
| JXH | Methyl Methacrylate For Aneurysmorrhaphy | Class II | 21 CFR 882.5030 | 3 | 0 |
| JXI | Cuff, Nerve | Class II | 21 CFR 882.5275 | 40 | 4 |
| JXK | Cranial Electrotherapy Stimulator To Treat Depression | Class III | 21 CFR 882.5800 | 0 | 3 |
| JXL | Block, Bite | Class II | 21 CFR 882.5070 | 28 | 0 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Class II | 21 CFR 862.3170 | 90 | 81 |
| JXN | Enzyme Immunoassay, Propoxyphene | Class II | 21 CFR 862.3700 | 22 | 2 |
| JXO | Enzyme Immunoassay, Cocaine | Class II | 21 CFR 862.3250 | 6 | 0 |
| JXQ | Monitor, U.V., Glc | Class I | 21 CFR 862.2250 | 0 | 0 |
| JXR | Atomic Absorption Spectrophotometer, General Use | Class I | 21 CFR 862.2850 | 29 | 0 |
| JXS | Block, Cutting, Ent, Sterile | Class I | 21 CFR 874.3540 | 2 | 0 |
| JXT | Crimper, Wire, Ent, Sterile | Class I | 21 CFR 874.3540 | 0 | 0 |
| JXW | Die, Wire Bending, Ent, Sterile | Class I | 21 CFR 874.3540 | 0 | 0 |
| JXX | Forceps, Wire Closure, Ent, Sterile | Class I | 21 CFR 874.3540 | 0 | 0 |
| JXY | Jig, Piston Cutting, Ent, Sterile | Class I | 21 CFR 874.3540 | 0 | 0 |
| JXZ | Punch, Gelfoam, Sterile | Class I | 21 CFR 874.3540 | 0 | 0 |
| JYA | Scissors, Wire Cutting, Ent, Sterile | Class I | 21 CFR 874.3540 | 0 | 0 |
| JYB | Vise, Ossicular Finger, Sterile | Class I | 21 CFR 874.3540 | 0 | 0 |
| JYC | Cannula, Ear | Class I | 21 CFR 878.4800 | 2 | 0 |
| JYD | Chisel, Mastoid | Class I | 21 CFR 878.4800 | 1 | 0 |
| JYE | Chisel, Middle-Ear | Class I | 21 CFR 874.4420 | 1 | 0 |
| JYF | Clamp, Ossicle Holding | Class I | 21 CFR 874.4420 | 0 | 0 |
| JYG | Curette, Ear | Class I | 21 CFR 874.4420 | 7 | 1 |
| JYH | Excavator, Ear | Class I | 21 CFR 874.4420 | 0 | 0 |
| JYI | Gauge, Mastoid | Class I | 21 CFR 874.4420 | 0 | 0 |
| JYJ | Gauge, Measuring | Class I | 21 CFR 874.4420 | 5 | 0 |
| JYK | Holder, Ear Speculum | Class I | 21 CFR 878.1800 | 1 | 0 |
| JYL | Hook, Microsurgical Ear | Class I | 21 CFR 874.4420 | 5 | 0 |
| JYM | Inserter, Myringotomy Tube | Class I | 21 CFR 874.4420 | 4 | 0 |
| JYN | Inserter, Sacculotomy Tack | Class I | 21 CFR 874.4420 | 0 | 0 |
| JYO | Knife, Ear | Class I | 21 CFR 874.4420 | 7 | 1 |
| JYP | Knife, Myringotomy | Class I | 21 CFR 874.4420 | 1 | 0 |
| JYQ | Loop, Wire | Class I | 21 CFR 874.4420 | 2 | 0 |
| JYR | Nipper, Malleus | Class I | 21 CFR 874.4420 | 2 | 0 |
| JYS | Perforator, Ear-Lobe | Class I | 21 CFR 874.4420 | 3 | 0 |
| JYT | Pick, Microsurgical Ear | Class I | 21 CFR 874.4420 | 2 | 0 |
| JYW | Press, Vein | Class I | 21 CFR 874.4420 | 1 | 0 |
| JYX | Punch, Attic | Class I | 21 CFR 874.4420 | 0 | 0 |
| JYY | Rasp, Ear | Class I | 21 CFR 874.4420 | 1 | 0 |
| JYZ | Rod, Measuring Ear | Class I | 21 CFR 874.4420 | 1 | 0 |
| JZA | Rongeur, Mastoid | Class I | 21 CFR 874.4420 | 1 | 0 |
| JZB | Scissors, Ear | Class I | 21 CFR 874.4420 | 4 | 0 |
| JZC | Searcher, Mastoid | Class I | 21 CFR 874.4420 | 0 | 0 |
| JZD | Snare, Ear | Class I | 21 CFR 874.4420 | 2 | 0 |
| JZE | Spoon, Ear | Class I | 21 CFR 874.4420 | 1 | 0 |
| JZF | Tube, Ear Suction | Class I | 21 CFR 874.4420 | 5 | 0 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | Class II | 21 CFR 866.5630 | 53 | 6 |
| JZH | Factor B, Antigen, Antiserum, Control | Class II | 21 CFR 866.5320 | 6 | 1 |
| JZJ | Prealbumin, Antigen, Antiserum, Control | Class I | 21 CFR 866.5060 | 11 | 1 |
| JZO | System, Test, Thyroid Autoantibody | Class II | 21 CFR 866.5870 | 92 | 18 |
| JZP | Plates, Ouchterlony Agar | Class I | 21 CFR 866.4600 | 1 | 0 |
| JZQ | Plates And Equipment, Radial Immunodiffusion | Class I | 21 CFR 866.4800 | 7 | 1 |
| JZR | Support Gels | Class I | 21 CFR 866.4900 | 2 | 0 |
| JZS | Electrophoresis Instrumentation | Class I | 21 CFR 866.4500 | 6 | 0 |
| JZT | Fluorometer | Class I | 21 CFR 866.4520 | 14 | 0 |
