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 |
|---|---|---|---|---|---|
| FEI | Instrument, Special Lens, For Endoscope | Class I | 21 CFR 876.1500 | 2 | 2 |
| FEJ | Attachment, Binocular, For Endoscope | Class I | 21 CFR 876.1500 | 1 | 0 |
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | Class I | 21 CFR 876.1500 | 4 | 5 |
| FEN | Device, Cystometric, Hydraulic | Class II | 21 CFR 876.1620 | 36 | 3 |
| FEO | Lithotriptor, Ultrasonic | Class II | 21 CFR 876.4480 | 14 | 7 |
| FEQ | Pump, Air, Non-Manual, For Endoscope | Class II | 21 CFR 876.1500 | 21 | 5 |
| FER | Anoscope And Accessories | Class II | 21 CFR 876.1500 | 27 | 1 |
| FES | Recorder, External, Pressure, Amplifier & Transducer | Class II | 21 CFR 876.1725 | 2 | 0 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Class II | 21 CFR 876.1500 | 101 | 8 |
| FEW | Catheter, Malecot | Class II | 21 CFR 876.5090 | 6 | 0 |
| FEX | Instrument, Catheter, Punch | Class I | 21 CFR 876.5090 | 2 | 0 |
| FEZ | Catheter And Tube, Suprapubic | Class II | 21 CFR 876.5090 | 1 | 2 |
| FFA | Tube, Drainage, Suprapubic | Class II | 21 CFR 876.5090 | 3 | 10 |
| FFD | Evacuator, Bladder, Manually Operated | Class I | 21 CFR 876.4370 | 2 | 0 |
| FFE | System, Water Jet Catheter, Renal | Class II | 21 CFR 876.4650 | 1 | 0 |
| FFF | Cover, Biopsy Forceps | Class I | 21 CFR 876.1075 | 1 | 5 |
| FFG | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | Class II | 21 CFR 876.1800 | 17 | 1 |
| FFH | Collector, Urine, Pediatric, For Indwelling Catheter | Class II | 21 CFR 876.5250 | 3 | 0 |
| FFI | System, Alarm, Electrosurgical | Class II | 21 CFR 876.4300 | 1 | 0 |
| FFK | Lithotriptor, Electro-Hydraulic | Class II | 21 CFR 876.4480 | 61 | 21 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | Class II | 21 CFR 876.4680 | 52 | 10 |
| FFN | Clamp, Non-Electrical | Class I | 21 CFR 876.4730 | 5 | 0 |
| FFO | Retractor, Self-Retaining | Class I | 21 CFR 876.4730 | 5 | 3 |
| FFP | Dilator, Rectal | Class I | 21 CFR 876.5450 | 5 | 0 |
| FFQ | Speculum, Rectal | Class I | 21 CFR 876.4730 | 1 | 0 |
| FFR | Device, Locking, For Intestinal Clamp | Class I | 21 CFR 876.4730 | 0 | 0 |
| FFS | Image, Illumination, Fiberoptic, For Endoscope | Class II | 21 CFR 876.1500 | 26 | 2 |
| FFT | Electrode, Ph, Stomach | Class I | 21 CFR 876.1400 | 49 | 11 |
| FFW | String And Tubes, Gastrointestinal, To Locate Internal Bleeding | Class II | 21 CFR 876.5980 | 0 | 0 |
| FFX | System, Gastrointestinal Motility (Electrical) | Class II | 21 CFR 876.1725 | 69 | 7 |
| FFY | Adaptor, Bulbs, Miscellaneous, For Endoscope | Class I | 21 CFR 876.1500 | 2 | 0 |
| FFZ | Cord, Electric, For Endoscope | Class II | 21 CFR 876.1500 | 3 | 1 |
| FGA | Kit, Nephroscope | Class II | 21 CFR 876.1500 | 10 | 8 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Class II | 21 CFR 876.1500 | 119 | 28 |
| FGC | Urethroscope | Class II | 21 CFR 876.1500 | 3 | 0 |
| FGD | Catheter, Retention, Barium Enema With Bag | Class II | 21 CFR 876.5980 | 6 | 0 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Class II | 21 CFR 876.5010 | 478 | 450 |
| FGF | Catheter, Ureteral Disposable (X-Ray) | Class II | 21 CFR 876.5130 | 1 | 0 |
| FGH | Catheter, Double Lumen Female Urethrographic | Class II | 21 CFR 876.5130 | 1 | 0 |
| FGI | Catheter, Urethrographic, Male | Class II | 21 CFR 876.5130 | 3 | 0 |
| FGK | Tripsor, Stone, Bladder | Class II | 21 CFR 876.4500 | 1 | 0 |
| FGM | Probe And Director, Gastro-Urology | Class I | 21 CFR 876.4730 | 7 | 1 |
| FGN | Retractor, Non-Self-Retaining | Class I | 21 CFR 876.4730 | 0 | 0 |
| FGO | Dislodger, Stone, Flexible | Class II | 21 CFR 876.4680 | 19 | 3 |
| FGS | Carrier, Sponge, Endoscopic | Class II | 21 CFR 876.1500 | 4 | 1 |
| FGW | Clamp, Electrical | Class II | 21 CFR 876.4300 | 0 | 0 |
| FGX | Snare, Non-Electrical | Class I | 21 CFR 876.4730 | 0 | 47 |
| FGY | Cannula, Injection | Class I | 21 CFR 878.4200 | 2 | 7 |
| FHA | Clamp, Penile | Class I | 21 CFR 876.5160 | 11 | 1 |
| FHB | Hook, Gastro-Urology | Class I | 21 CFR 876.4730 | 0 | 0 |
| FHC | Adaptor To The Cord, For Transurethral Surgical Instrument | Class II | 21 CFR 876.4300 | 0 | 0 |
| FHF | System, Evacuator, Fluid | Class II | 21 CFR 876.4370 | 3 | 0 |
| FHG | Bell, Circumcision | Class II | 21 CFR 884.4530 | 2 | 0 |
| FHH | Crusher, Spur, Colostomy | Class I | 21 CFR 876.4730 | 0 | 0 |
| FHI | Ring, Laparotomy | Class I | 21 CFR 876.4730 | 0 | 10 |
| FHJ | Shield, Circumcision | Class II | 21 CFR 884.4530 | 2 | 0 |
| FHK | Spreader, Bladder Neck | Class I | 21 CFR 876.4730 | 0 | 0 |
| FHL | Scoop | Class I | 21 CFR 876.4730 | 0 | 0 |
| FHM | Apparatus, Suturing, Stomach And Intestinal | Class I | 21 CFR 878.4800 | 2 | 0 |
| FHN | Ligator, Hemorrhoidal | Class II | 21 CFR 876.4400 | 22 | 5 |
| FHO | Pneumoperitoneum Needle | Class II | 21 CFR 876.1500 | 15 | 0 |
| FHP | Needle, Pneumoperitoneum, Simple | Class II | 21 CFR 876.1500 | 2 | 0 |
| FHQ | Holder, Needle, Gastroenterologic | Class I | 21 CFR 876.4730 | 7 | 4 |
| FHR | Needle, Gastro-Urology | Class I | 21 CFR 878.4800 | 1 | 0 |
| FHS | Dialyzer, Single Coil | Class II | 21 CFR 876.5820 | 12 | 0 |
| FHT | Set, Gavage, Infant, Sterile | Class II | 21 CFR 876.5980 | 1 | 0 |
| FHW | Device, Impotence, Mechanical/Hydraulic | Class III | 21 CFR 876.3350 | 0 | 20 |
| FHX | Jelly, Lubricating, For Transurethral Surgical Instrument | Class II | 21 CFR 876.1500 | 6 | 0 |
| FHY | Jelly, Contact, For Transurethral Surgical Instrument | Class II | 21 CFR 876.4300 | 0 | 0 |
| FHZ | Desiccator, Transurethral | Class II | 21 CFR 876.4300 | 0 | 0 |
| FIA | Chair, Dialysis, Unpowered, Without Scales | Class I | 21 CFR 876.5820 | 0 | 0 |
| FIB | Protector, Transducer, Dialysis | Class II | 21 CFR 876.5820 | 35 | 0 |
| FID | Tubing, Dialysate | Class II | 21 CFR 876.5820 | 3 | 0 |
| FIE | Needle, Fistula | Class II | 21 CFR 876.5540 | 80 | 7 |
| FIF | Set, Dialysis, Single Needle With Uni-Directional Pump | Class II | 21 CFR 876.5820 | 6 | 0 |
| FIG | Clamp, Tubing, Blood, Automatic | Class II | 21 CFR 876.5820 | 4 | 0 |
| FIH | Pump, Infusion Or Syringe, Extra-Luminal | Class II | 21 CFR 876.5820 | 5 | 0 |
| FII | System, Dialysate Delivery, Sealed | Class II | 21 CFR 876.5860 | 5 | 2 |
| FIJ | System, Dialysate Delivery, Recirculating, Single Pass | Class II | 21 CFR 876.5820 | 1 | 0 |
| FIK | System, Dialysate Delivery, Recirculating | Class II | 21 CFR 876.5820 | 0 | 1 |
| FIL | System, Dialysate Delivery, Single Pass | Class II | 21 CFR 876.5820 | 8 | 0 |
| FIN | Tank, Holding, Dialysis | Class II | 21 CFR 876.5820 | 18 | 4 |
| FIP | Subsystem, Water Purification | Class II | 21 CFR 876.5665 | 117 | 15 |
| FIQ | Cannula, A-V Shunt | Class II | 21 CFR 876.5540 | 23 | 0 |
| FIR | Pump, Blood, Extra-Luminal | Class II | 21 CFR 876.5820 | 7 | 3 |
| FIS | Flowmeter, Dialysate | Class II | 21 CFR 876.5820 | 0 | 0 |
| FIW | Alarm, Pillow Pressure | Class II | 21 CFR 876.5820 | 1 | 0 |
| FIZ | Meter, Conductivity, Non-Remote | Class II | 21 CFR 876.5820 | 13 | 0 |
| FJA | Manometer, Water | Class II | 21 CFR 876.5820 | 0 | 0 |
| FJB | Detector, Dialysate Level | Class II | 21 CFR 876.5820 | 3 | 0 |
| FJC | Detector, Blood Level | Class II | 21 CFR 876.5820 | 1 | 0 |
| FJD | Detector, Leak, Blood | Class II | 21 CFR 876.5820 | 4 | 0 |
| FJF | Detector, Air Bubble | Class II | 21 CFR 876.5820 | 5 | 0 |
| FJG | Dialyzer, Parallel Flow | Class II | 21 CFR 876.5820 | 36 | 0 |
| FJH | Dialyzer, Disposable | Class II | 21 CFR 876.5830 | 4 | 0 |
| FJI | Dialyzer, Capillary, Hollow Fiber | Class II | 21 CFR 876.5820 | 131 | 7 |
| FJJ | Dialyzer, Twin Coil | Class II | 21 CFR 876.5820 | 0 | 0 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | Class II | 21 CFR 876.5820 | 77 | 36 |
| FJL | Resectoscope | Class II | 21 CFR 876.1500 | 24 | 33 |
| FJM | Guard, Shunt | Class II | 21 CFR 876.5540 | 0 | 0 |
