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 |
|---|---|---|---|---|---|
| IPS | Cane | Class I | 21 CFR 890.3075 | 9 | 4 |
| IPT | Orthosis, Thoracic | Class I | 21 CFR 890.3490 | 5 | 0 |
| IPW | Orthosis, Sacroiliac, Soft | Class I | 21 CFR 890.3490 | 1 | 0 |
| IPX | Orthosis, Rib Fracture, Soft | Class I | 21 CFR 890.3490 | 3 | 0 |
| IPY | Orthosis, Lumbo-Sacral | Class I | 21 CFR 890.3490 | 11 | 1 |
| IQA | System, Environmental Control, Powered | Class II | 21 CFR 890.3725 | 24 | 17 |
| IQB | Belt, Wheelchair | Class I | 21 CFR 890.3920 | 2 | 0 |
| IQC | Wheelchair, Special Grade | Class II | 21 CFR 890.3880 | 24 | 0 |
| IQE | Orthosis, Lumbar | Class I | 21 CFR 890.3490 | 4 | 0 |
| IQF | Orthosis, Cervical-Thoracic, Rigid | Class I | 21 CFR 890.3490 | 7 | 0 |
| IQG | Adaptor, Holder, Syringe | Class I | 21 CFR 890.5050 | 3 | 0 |
| IQI | Orthosis, Limb Brace | Class I | 21 CFR 890.3475 | 52 | 17 |
| IQJ | Splint, Clavicle | Class I | 21 CFR 890.3490 | 4 | 0 |
| IQK | Orthosis, Cervical | Class I | 21 CFR 890.3490 | 27 | 6 |
| IQM | Splint, Temporary Training | Class I | 21 CFR 890.3025 | 3 | 0 |
| IQO | Device, Prosthesis Alignment | Class I | 21 CFR 890.3025 | 0 | 2 |
| IQP | Rotator, Transverse | Class I | 21 CFR 890.3025 | 1 | 0 |
| IQQ | Joint, Shoulder, External Limb Component | Class I | 21 CFR 890.3420 | 0 | 0 |
| IQW | Hook, External Limb Component, Powered | Class I | 21 CFR 890.3420 | 0 | 0 |
| IQX | Hook, External Limb Component, Mechanical | Class I | 21 CFR 890.3420 | 1 | 0 |
| IQZ | Hand, External Limb Component, Powered | Class I | 21 CFR 890.3420 | 0 | 2 |
| IRA | Hand, External Limb Component, Mechanical | Class I | 21 CFR 890.3420 | 2 | 0 |
| IRD | Joint, Elbow, External Limb Component, Mechanical | Class I | 21 CFR 890.3420 | 0 | 0 |
| IRE | Joint, Elbow, External Limb Component, Powered | Class I | 21 CFR 890.3420 | 2 | 0 |
| IRN | Device, Warning, Overload, External Limb, Powered | Class II | 21 CFR 890.5575 | 11 | 0 |
| IRO | Vibrator, Therapeutic | Class I | 21 CFR 890.5975 | 65 | 2 |
| IRP | Massager, Powered Inflatable Tube | Class II | 21 CFR 890.5650 | 156 | 5 |
| IRQ | Unit, Heating, Powered | Class I | 21 CFR 890.5950 | 7 | 1 |
| IRR | Bars, Parallel, Powered | Class I | 21 CFR 890.5380 | 1 | 0 |
| IRS | Head Halter, Traction | Class I | 21 CFR 890.5925 | 1 | 0 |
| IRT | Pad, Heating, Powered | Class II | 21 CFR 890.5740 | 42 | 24 |
| ISA | Massager, Therapeutic, Electric | Class I | 21 CFR 890.5660 | 100 | 10 |
| ISB | Stimulator, Muscle, Diagnostic | Class II | 21 CFR 890.1850 | 5 | 0 |
| ISD | Exerciser, Measuring | Class II | 21 CFR 890.5360 | 61 | 2 |
| ISH | Component, External, Limb, Ankle/Foot | Class I | 21 CFR 890.3420 | 4 | 13 |
| ISL | Joint, Hip, External Limb Component | Class I | 21 CFR 890.3420 | 0 | 1 |
| ISM | Pylon, Post Surgical | Class I | 21 CFR 890.3025 | 0 | 1 |
| ISN | Cable | Class I | 21 CFR 890.3420 | 0 | 0 |
| ISP | Valve, Prosthesis | Class I | 21 CFR 890.3420 | 1 | 1 |
| ISR | Band Or Belt, Pelvic Support | Class I | 21 CFR 890.3025 | 1 | 0 |
| ISS | Prosthesis, Thigh Socket, External Component | Class I | 21 CFR 890.3420 | 1 | 0 |
| ISW | Assembly, Knee/Shank/Ankle/Foot, External | Class II | 21 CFR 890.3500 | 1 | 10 |
| ISY | Joint, Knee, External Limb Component | Class I | 21 CFR 890.3420 | 1 | 17 |
| ISZ | Unit, Wrist, External Limb Component, Mechanical | Class I | 21 CFR 890.3420 | 0 | 0 |
| ITC | Stirrup, External Brace Component | Class I | 21 CFR 890.3410 | 0 | 0 |
| ITG | Bandage, Cast | Class I | 21 CFR 890.3025 | 37 | 3 |
| ITH | Equipment, Traction, Powered | Class II | 21 CFR 890.5900 | 71 | 5 |
| ITI | Wheelchair, Powered | Class II | 21 CFR 890.3860 | 590 | 71 |
| ITJ | Walker, Mechanical | Class I | 21 CFR 890.3825 | 14 | 27 |
| ITM | Cage, Knee | Class I | 21 CFR 890.3475 | 5 | 0 |
| ITN | Splint, Denis Brown | Class I | 21 CFR 890.3675 | 3 | 0 |
| ITO | Twister, Brace Setting | Class I | 21 CFR 890.3410 | 1 | 0 |
| ITQ | Joint, Knee, External Brace | Class I | 21 CFR 890.3475 | 15 | 12 |
| ITS | Joint, Hip, External Brace | Class I | 21 CFR 890.3475 | 1 | 0 |
| ITW | Joint, Ankle, External Brace | Class I | 21 CFR 890.3475 | 1 | 3 |
| ITX | Transducer, Ultrasonic, Diagnostic | Class II | 21 CFR 892.1570 | 415 | 147 |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | Class I | 21 CFR 892.1760 | 40 | 4 |
| ITZ | Assembly, Tube Housing, X-Ray, Therapeutic | Class II | 21 CFR 892.5930 | 0 | 0 |
| IWA | Source, Wire, Iridium, Radioactive | Class II | 21 CFR 892.5730 | 8 | 0 |
| IWB | System, Radiation Therapy, Radionuclide | Class II | 21 CFR 892.5750 | 48 | 29 |
| IWD | Device, Beam Limiting, Teletherapy, Radionuclide | Class II | 21 CFR 892.5750 | 1 | 0 |
| IWE | Monitor, Patient Position, Light-Beam | Class I | 21 CFR 892.5780 | 28 | 8 |
| IWF | Needle, Isotope, Gold, Titanium, Platinum | Class II | 21 CFR 892.5730 | 0 | 1 |
| IWG | Seed, Isotope, Gold, Titanium, Platinum | Class II | 21 CFR 892.5730 | 3 | 0 |
| IWH | Source, Teletherapy, Radionuclide | Class I | 21 CFR 892.5740 | 0 | 0 |
| IWI | Source, Isotope, Sealed, Gold, Titanium, Platinum | Class II | 21 CFR 892.5730 | 6 | 0 |
| IWJ | System, Applicator, Radionuclide, Manual | Class I | 21 CFR 892.5650 | 36 | 11 |
| IWK | Cyclotron, Medical | Class II | 21 CFR 892.5050 | 0 | 0 |
| IWL | System, Radiation Therapy, Neutron, Medical | Class II | 21 CFR 892.5300 | 4 | 0 |
| IWM | Synchrotron, Medical | Class II | 21 CFR 892.5050 | 1 | 0 |
| IWN | Cassette, Measurement, Ardran-Crooks | Class I | 21 CFR 892.1940 | 1 | 0 |
| IWO | Apron, Protective | Class I | 21 CFR 892.6500 | 1 | 13 |
| IWP | Radiographic Protective Glove | Class I | 21 CFR 892.6500 | 5 | 0 |
| IWQ | Curtain, Protective, Radiographic | Class I | 21 CFR 892.6500 | 3 | 0 |
| IWR | Holder, Syringe, Lead | Class I | 21 CFR 892.6500 | 4 | 0 |
| IWS | Shield, Eye, Radiological | Class I | 21 CFR 892.6500 | 6 | 0 |
| IWT | Shield, Gonadal | Class I | 21 CFR 892.6500 | 2 | 0 |
| IWW | Shield, Vial | Class I | 21 CFR 892.6500 | 1 | 0 |
| IWX | Barrier, Control Panel, X-Ray, Movable | Class I | 21 CFR 892.6500 | 3 | 1 |
| IWY | Holder, Head, Radiographic | Class I | 21 CFR 892.1920 | 10 | 1 |
| IWZ | Film, Radiographic | Class I | 21 CFR 892.1840 | 34 | 13 |
| IXA | Cassette, Radiographic Film | Class II | 21 CFR 892.1850 | 51 | 1 |
| IXC | Illuminator, Radiographic-Film | Class I | 21 CFR 892.1890 | 18 | 0 |
| IXD | Source, Calibration, Sealed, Nuclear | Class I | 21 CFR 892.1400 | 2 | 0 |
| IXF | Test-Pattern, Radiographic | Class I | 21 CFR 892.1940 | 5 | 0 |
| IXG | Phantom, Anthropomorphic, Radiographic | Class I | 21 CFR 892.1950 | 4 | 0 |
| IXH | Camera, Focal Spot, Radiographic | Class I | 21 CFR 892.1940 | 2 | 0 |
| IXI | Block, Beam-Shaping, Radiation Therapy | Class II | 21 CFR 892.5710 | 51 | 6 |
| IXJ | Grid, Radiographic | Class I | 21 CFR 892.1910 | 15 | 1 |
| IXK | System, Imaging, X-Ray, Electrostatic | Class II | 21 CFR 892.1630 | 14 | 0 |
| IXL | Device, Spot-Film | Class II | 21 CFR 892.1670 | 13 | 3 |
| IXO | Synchronizer, Ecg / Respirator, Radiographic | Class I | 21 CFR 892.1970 | 4 | 0 |
| IXQ | Table, Radiographic, Stationary Top | Class II | 21 CFR 892.1980 | 27 | 7 |
| IXR | Table, Radiographic, Tilting | Class II | 21 CFR 892.1980 | 77 | 26 |
| IXW | Processor, Radiographic-Film, Automatic | Class II | 21 CFR 892.1900 | 83 | 1 |
| IXX | Processor, Cine Film | Class II | 21 CFR 892.1900 | 6 | 0 |
| IXY | Holder, Radiographic Cassette, Wall-Mounted | Class I | 21 CFR 892.1880 | 21 | 5 |
| IYB | Tube Mount, X-Ray, Diagnostic | Class I | 21 CFR 892.1770 | 40 | 13 |
| IYC | Generator, Orthovoltage, Therapeutic X-Ray | Class II | 21 CFR 892.5900 | 0 | 0 |
| IYD | Generator, Low Voltage, Therapeutic X-Ray | Class II | 21 CFR 892.5900 | 1 | 0 |
