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 |
|---|---|---|---|---|---|
| JZW | Nephelometer | Class I | 21 CFR 866.4540 | 11 | 1 |
| JZX | Equipment, Rocket Immunoelectrophoresis | Class I | 21 CFR 866.4830 | 1 | 0 |
| JZY | Knife, Laryngeal | Class I | 21 CFR 874.4420 | 0 | 0 |
| JZZ | Saw, Laryngeal | Class I | 21 CFR 874.4420 | 0 | 0 |
| KAA | Set, Laryngeal Injection | Class I | 21 CFR 874.4420 | 0 | 0 |
| KAB | Trocar, Laryngeal | Class I | 21 CFR 874.4420 | 1 | 0 |
| KAC | Tube, Laryngectomy | Class I | 21 CFR 874.4420 | 4 | 1 |
| KAD | Elevator, Ent | Class I | 21 CFR 874.4420 | 5 | 1 |
| KAE | Forceps, Ent | Class I | 21 CFR 874.4420 | 14 | 1 |
| KAG | Holder, Speculum, Ent | Class I | 21 CFR 878.1800 | 2 | 0 |
| KAH | Microrule, Ent | Class I | 21 CFR 874.4420 | 0 | 0 |
| KAI | Mirror, Ent | Class I | 21 CFR 874.4420 | 9 | 1 |
| KAJ | Mobilizer, Ent | Class I | 21 CFR 874.4420 | 0 | 0 |
| KAK | Probe, Ent | Class I | 21 CFR 874.4420 | 1 | 1 |
| KAL | Retractor, Ent | Class I | 21 CFR 874.4420 | 5 | 1 |
| KAM | Cannula, Sinus | Class I | 21 CFR 878.4800 | 19 | 2 |
| KAN | Chisel, Nasal | Class I | 21 CFR 878.4800 | 0 | 0 |
| KAO | Curette, Ethmoid | Class I | 21 CFR 874.4420 | 0 | 0 |
| KAP | Curette, Nasal | Class I | 21 CFR 874.4420 | 1 | 0 |
| KAQ | Gouge, Nasal, Ent | Class I | 21 CFR 874.4420 | 0 | 0 |
| KAR | Irrigator, Sinus | Class I | 21 CFR 874.4420 | 3 | 0 |
| KAS | Knife, Nasal | Class I | 21 CFR 874.4420 | 1 | 0 |
| KAT | Perforator, Antrum | Class I | 21 CFR 874.4420 | 0 | 0 |
| KAW | Punch, Antrum | Class I | 21 CFR 874.4420 | 0 | 0 |
| KAX | Punch, Ethmoid | Class I | 21 CFR 874.4420 | 0 | 0 |
| KAY | Punch, Nasal | Class I | 21 CFR 874.4420 | 0 | 0 |
| KAZ | Rasp, Frontal-Sinus | Class I | 21 CFR 874.4420 | 0 | 0 |
| KBA | Rasp, Nasal | Class I | 21 CFR 874.4420 | 0 | 0 |
| KBB | Rongeur, Nasal | Class I | 21 CFR 874.4420 | 0 | 0 |
| KBC | Saw, Nasal | Class I | 21 CFR 874.4420 | 4 | 0 |
| KBD | Scissors, Nasal | Class I | 21 CFR 874.4420 | 3 | 0 |
| KBE | Snare, Nasal | Class I | 21 CFR 874.4420 | 0 | 0 |
| KBF | Trephine, Sinus | Class I | 21 CFR 874.4420 | 1 | 0 |
| KBG | Trocar, Sinus | Class I | 21 CFR 874.4420 | 3 | 0 |
| KBH | Adenotome | Class I | 21 CFR 874.4420 | 1 | 0 |
| KBI | Bougie, Eustachian | Class I | 21 CFR 874.4175 | 1 | 0 |
| KBJ | Curette, Adenoid | Class I | 21 CFR 874.4420 | 1 | 1 |
| KBK | Curette, Salpingeal | Class I | 21 CFR 874.4420 | 0 | 0 |
| KBL | Depressor, Metal Tongue, Surgical | Class I | 21 CFR 874.4420 | 1 | 0 |
| KBM | Dissector, Tonsil | Class I | 21 CFR 874.4420 | 1 | 0 |
| KBN | Gag, Mouth | Class I | 21 CFR 874.4420 | 3 | 1 |
| KBO | Guillotine, Tonsil | Class I | 21 CFR 874.4420 | 1 | 0 |
| KBP | Hook, Tonsil Suturing | Class I | 21 CFR 874.4420 | 0 | 0 |
| KBQ | Knife, Tonsil | Class I | 21 CFR 874.4420 | 1 | 0 |
| KBR | Needle, Tonsil Suturing | Class I | 21 CFR 874.4420 | 0 | 0 |
| KBS | Punch, Adenoid | Class I | 21 CFR 874.4420 | 0 | 0 |
| KBT | Punch, Tonsil | Class I | 21 CFR 874.4420 | 0 | 0 |
| KBW | Screw, Oral | Class I | 21 CFR 874.4420 | 1 | 1 |
| KBX | Screw, Tonsil | Class I | 21 CFR 874.4420 | 0 | 0 |
| KBY | Set, Filliform, Eustachian | Class I | 21 CFR 874.4175 | 0 | 0 |
| KBZ | Snare, Tonsil | Class I | 21 CFR 874.4420 | 1 | 0 |
| KCA | Tonsillectome | Class I | 21 CFR 874.4420 | 1 | 0 |
| KCB | Tube, Tonsil Suction | Class I | 21 CFR 874.4420 | 1 | 1 |
| KCC | Bistoury, Tracheal | Class I | 21 CFR 874.4420 | 0 | 0 |
| KCD | Bougie, Esophageal, Ent | Class I | 21 CFR 874.4420 | 3 | 0 |
| KCE | Cannulae, Bronchial | Class I | 21 CFR 878.4800 | 0 | 0 |
| KCF | Dilator, Esophageal, Ent | Class I | 21 CFR 874.4420 | 3 | 0 |
| KCG | Dilator, Tracheal | Class I | 21 CFR 874.4420 | 1 | 1 |
| KCH | Hook, Tracheal | Class I | 21 CFR 874.4420 | 0 | 0 |
| KCI | Trocar, Tracheal | Class I | 21 CFR 874.4420 | 0 | 0 |
| KCJ | Applicator, Ent | Class I | 21 CFR 874.5220 | 4 | 1 |
| KCL | Blower, Powder, Ent | Class I | 21 CFR 874.5220 | 0 | 0 |
| KCM | Dropper, Ent | Class I | 21 CFR 874.5220 | 1 | 2 |
| KCN | Ear Wick | Class I | 21 CFR 874.5220 | 4 | 6 |
| KCO | Nasal Spray, Ent Delivery | Class I | 21 CFR 874.5220 | 1 | 1 |
| KCP | Syringe, Ent | Class I | 21 CFR 874.5220 | 4 | 1 |
| KCQ | Tube Impression And Matrix | Class I | 21 CFR 872.6570 | 1 | 0 |
| KCR | Facebow | Class I | 21 CFR 872.3220 | 1 | 0 |
| KCS | Pantograph | Class I | 21 CFR 872.3730 | 0 | 0 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | 21 CFR 880.6850 | 282 | 38 |
| KCW | Epilator, High Frequency, Needle-Type | Class I | 21 CFR 878.5350 | 43 | 0 |
| KCX | Epilator, High Frequency, Tweezer-Type | Class I | 21 CFR 878.5360 | 25 | 0 |
| KCY | Tourniquet, Pneumatic | Class I | 21 CFR 878.5910 | 34 | 47 |
| KCZ | Prosthesis, Breast, External, Used With Adhesive | Class I | 21 CFR 878.3800 | 13 | 1 |
| KDA | Prosthesis, Ptfe/Carbon-Fiber | Class II | 21 CFR 878.3500 | 1 | 0 |
| KDC | Instrument, Surgical, Disposable | Class I | 21 CFR 878.4800 | 67 | 38 |
| KDD | Kit, Surgical Instrument, Disposable | Class I | 21 CFR 878.4800 | 62 | 251 |
| KDG | Chisel (Osteotome) | Class I | 21 CFR 878.4820 | 11 | 14 |
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | Class II | 21 CFR 876.5980 | 23 | 2 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Class II | 21 CFR 876.5860 | 345 | 217 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | Class II | 21 CFR 876.5630 | 113 | 61 |
| KDK | Container, Transport, Kidney | Class II | 21 CFR 876.5880 | 3 | 0 |
| KDL | Set, Perfusion, Kidney, Disposable | Class II | 21 CFR 876.5880 | 19 | 4 |
| KDM | Sigmoidoscope, Rigid, Non-Electrical | Class II | 21 CFR 876.1500 | 1 | 1 |
| KDN | System, Perfusion, Kidney | Class II | 21 CFR 876.5880 | 44 | 6 |
| KDO | Rongeur, Cystoscopic, Hot | Class II | 21 CFR 876.1500 | 1 | 0 |
| KDP | Regulator, Vacuum | Class II | 21 CFR 880.6740 | 21 | 4 |
| KDQ | Bottle, Collection, Vacuum | Class II | 21 CFR 880.6740 | 48 | 33 |
| KDT | Container, Specimen Mailer And Storage, Sterile | Class I | 21 CFR 864.3250 | 12 | 17 |
| KDW | Container, Specimen Mailer And Storage, Temperature Controlled, Sterile | Class I | 21 CFR 864.3250 | 4 | 0 |
| KDX | Solution, Decalcifier, Acid Containing | Class I | 21 CFR 864.4010 | 8 | 0 |
| KDY | Agent, Chelating For Decalcification | Class I | 21 CFR 864.4010 | 0 | 0 |
| KDZ | Device, Decalcifier, Electrolytic | Class I | 21 CFR 864.3010 | 0 | 0 |
| KEA | Resins, Ion-Exchange | Class I | 21 CFR 862.2230 | 9 | 0 |
| KEE | Osmium Tetroxide | Class I | 21 CFR 864.4010 | 0 | 0 |
| KEF | Paraformaldehyde | Class I | 21 CFR 864.4010 | 0 | 0 |
| KEG | Lamps, Microscope | Class I | 21 CFR 864.3600 | 0 | 0 |
| KEH | Micrometers, Microscope | Class I | 21 CFR 864.3600 | 0 | 0 |
| KEI | Condensers, Microscope | Class I | 21 CFR 864.3600 | 0 | 0 |
| KEJ | Stages, Microscope | Class I | 21 CFR 864.3600 | 1 | 0 |
