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 |
|---|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Class II | 21 CFR 892.5050 | 738 | 563 |
| IYG | Betatron, Medical | Class II | 21 CFR 892.5050 | 0 | 0 |
| IYH | Generator, Dermatological (Grenz Ray), Therapeutic X-Ray | Class II | 21 CFR 892.5900 | 1 | 1 |
| IYI | Collimator, Orthovoltage, Therapeutic X-Ray | Class II | 21 CFR 892.5900 | 2 | 0 |
| IYJ | Collimator, Low Voltage, Therapeutic X-Ray | Class II | 21 CFR 892.5900 | 0 | 0 |
| IYK | Collimator, High Voltage, Therapeutic X-Ray | Class II | 21 CFR 892.5900 | 0 | 0 |
| IYL | Collimator, Dermatological, Therapeutic X-Ray | Class II | 21 CFR 892.5900 | 1 | 0 |
| IYM | System, Telethermographic, Infrared | Class III | 21 CFR 884.2980 | 8 | 0 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Class II | 21 CFR 892.1550 | 1,185 | 299 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Class II | 21 CFR 892.1560 | 895 | 83 |
| IYP | Phantom, Anthropomorphic, Nuclear | Class I | 21 CFR 892.1370 | 3 | 0 |
| IYQ | Phantom, Flood Source, Nuclear | Class I | 21 CFR 892.1380 | 0 | 0 |
| IYT | System, Rebreathing, Radionuclide | Class II | 21 CFR 892.1390 | 49 | 0 |
| IYW | Scanner, Rectilinear, Nuclear | Class I | 21 CFR 892.1300 | 4 | 0 |
| IYX | Camera, Scintillation (Gamma) | Class I | 21 CFR 892.1100 | 130 | 7 |
| IYY | Synchronizer, Electrocardiograph, Nuclear | Class I | 21 CFR 892.1410 | 3 | 0 |
| IYZ | Bed, Scanning, Nuclear | Class I | 21 CFR 892.1350 | 12 | 0 |
| IZC | Camera, Positron | Class I | 21 CFR 892.1110 | 0 | 0 |
| IZD | Probe, Uptake, Nuclear | Class I | 21 CFR 892.1320 | 30 | 10 |
| IZF | System, X-Ray, Tomographic | Class II | 21 CFR 892.1740 | 42 | 6 |
| IZG | System, X-Ray, Photofluorographic | Class II | 21 CFR 892.1730 | 7 | 0 |
| IZH | System, X-Ray, Mammographic | Class II | 21 CFR 892.1710 | 176 | 14 |
| IZI | System, X-Ray, Angiographic | Class II | 21 CFR 892.1600 | 199 | 259 |
| IZJ | Camera, X-Ray, Fluorographic, Cine Or Spot | Class II | 21 CFR 892.1620 | 12 | 2 |
| IZL | System, X-Ray, Mobile | Class II | 21 CFR 892.1720 | 237 | 170 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | Class I | 21 CFR 892.1700 | 163 | 4 |
| IZP | Programmer, Changer, Film/Cassette, Radiographic | Class II | 21 CFR 892.1870 | 10 | 0 |
| IZQ | Injector, Contrast Medium, Automatic | Class II | 21 CFR 870.1650 | 23 | 3 |
| IZS | Aperture, Radiographic | Class II | 21 CFR 892.1610 | 1 | 0 |
| IZT | Cone, Radiographic | Class II | 21 CFR 892.1610 | 1 | 0 |
| IZW | Collimator, Automatic, Radiographic | Class II | 21 CFR 892.1610 | 23 | 3 |
| IZX | Collimator, Manual, Radiographic | Class II | 21 CFR 892.1610 | 17 | 4 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | Class II | 21 CFR 892.1980 | 29 | 19 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Class II | 21 CFR 892.1650 | 300 | 223 |
| JAB | System, X-Ray, Fluoroscopic, Non-Image-Intensified | Class II | 21 CFR 892.1660 | 2 | 0 |
| JAC | System, X-Ray, Film Marking, Radiographic | Class I | 21 CFR 892.1640 | 18 | 15 |
| JAD | System, Therapeutic, X-Ray | Class II | 21 CFR 892.5900 | 53 | 12 |
| JAE | Microtron, Medical | Class II | 21 CFR 892.5050 | 0 | 0 |
| JAF | Monitor, Ultrasonic, Nonfetal | Class II | 21 CFR 892.1540 | 38 | 8 |
| JAG | Illuminator, Radiographic-Film, Explosion-Proof | Class I | 21 CFR 892.1890 | 0 | 0 |
| JAI | Couch, Radiation Therapy, Powered | Class II | 21 CFR 892.5770 | 32 | 18 |
| JAK | System, X-Ray, Tomography, Computed | Class II | 21 CFR 892.1750 | 825 | 871 |
| JAM | Scanner, Whole Body, Nuclear | Class I | 21 CFR 892.1330 | 3 | 0 |
| JAN | Counter, Whole Body, Nuclear | Class I | 21 CFR 892.1130 | 0 | 0 |
| JAO | Scanner, Fluorescent | Class II | 21 CFR 892.1220 | 2 | 0 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | Class II | 21 CFR 892.5700 | 208 | 52 |
| JAR | Phantom, Test-Pattern, Radionuclide | Class I | 21 CFR 892.1420 | 0 | 0 |
| JAX | Pneumotachometer | Class II | 21 CFR 868.2550 | 8 | 1 |
| JAY | Support, Breathing Tube | Class I | 21 CFR 868.5280 | 19 | 2 |
| JAZ | Prosthesis, Facial, Mandibular Implant | Class II | 21 CFR 874.3695 | 2 | 0 |
| JBB | Solubility, Hemoglobin, Abnormal | Class II | 21 CFR 864.7825 | 2 | 0 |
| JBD | System, Analysis, Electrophoretic Hemoglobin | Class II | 21 CFR 864.7440 | 26 | 3 |
| JBE | Cell Enzymes (Erythrocytic And Leukocytic) | Class II | 21 CFR 864.7100 | 1 | 0 |
| JBF | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | Class II | 21 CFR 864.7360 | 5 | 1 |
| JBG | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot | Class II | 21 CFR 864.7360 | 0 | 0 |
| JBH | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod | Class II | 21 CFR 864.7360 | 0 | 0 |
| JBI | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition | Class II | 21 CFR 864.7360 | 0 | 0 |
| JBJ | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction | Class II | 21 CFR 864.7360 | 0 | 0 |
| JBK | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic | Class II | 21 CFR 864.7360 | 0 | 0 |
| JBL | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative | Class II | 21 CFR 864.7360 | 2 | 2 |
| JBM | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis | Class II | 21 CFR 864.7360 | 0 | 0 |
| JBN | Fibrin Monomer Paracoagulation | Class II | 21 CFR 864.7300 | 2 | 0 |
| JBO | Test, Euglobulin Lysis | Class II | 21 CFR 864.7275 | 1 | 0 |
| JBP | Activated Whole Blood Clotting Time | Class II | 21 CFR 864.7140 | 24 | 10 |
| JBQ | Antithrombin Iii Quantitation | Class II | 21 CFR 864.7060 | 56 | 0 |
| JBR | Test, Heparin Neutralization | Class II | 21 CFR 864.7525 | 3 | 0 |
| JBS | Timer, General Laboratory | Class I | 21 CFR 862.2050 | 0 | 2 |
| JBT | Timer, Coagulation | Class II | 21 CFR 864.5400 | 0 | 0 |
| JBW | Red-Cell Indices, Measured | Class II | 21 CFR 864.5300 | 0 | 0 |
| JBX | Aggregrometer, Platelet | Class II | 21 CFR 864.6675 | 12 | 0 |
| JBY | Aggregometer, Platelet, Photo-Optical Scanning | Class II | 21 CFR 864.6675 | 2 | 0 |
| JBZ | Study, Platelet Adhesive | Class II | 21 CFR 864.6650 | 3 | 0 |
| JCA | Device, Bleeding Time | Class II | 21 CFR 864.6100 | 7 | 1 |
| JCB | Detergent | Class I | 21 CFR 864.4010 | 0 | 3 |
| JCC | Ph Buffer | Class I | 21 CFR 864.4010 | 7 | 2 |
| JCE | Solution, Isotonic | Class I | 21 CFR 864.4010 | 7 | 0 |
| JCF | Lymphocyte Separation Medium | Class I | 21 CFR 864.8500 | 12 | 4 |
| JCG | Fluid, Diluting, Manual Cell | Class I | 21 CFR 864.8200 | 1 | 0 |
| JCH | Esterase | Class I | 21 CFR 864.1850 | 0 | 0 |
| JCI | Acid Phosphatase, Cytochemical | Class I | 21 CFR 864.1850 | 0 | 0 |
| JCJ | Alkaline Phosphatase | Class I | 21 CFR 864.7660 | 0 | 0 |
| JCM | Control, Hemoglobin, Abnormal | Class II | 21 CFR 864.7415 | 12 | 1 |
| JCN | Control, Cell Counter, Normal And Abnormal | Class II | 21 CFR 864.8625 | 12 | 3 |
| JCO | Bothrops Atrox Reagent | Class II | 21 CFR 864.8100 | 7 | 0 |
| JCQ | Prosthesis, Esophagus | Class II | 21 CFR 878.3610 | 1 | 0 |
| JCT | Prosthesis, Tracheal, Expandable | Class II | 21 CFR 878.3720 | 45 | 61 |
| JCW | Prosthesis, Penis, Inflatable | Class III | 21 CFR 876.3350 | 0 | 19 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | Class II | 21 CFR 878.4780 | 77 | 24 |
| JCY | Catheter, Infusion | Class I | 21 CFR 878.4200 | 14 | 3 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | Class II | 21 CFR 888.3160 | 27 | 26 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | Class II | 21 CFR 888.3150 | 29 | 21 |
| JDD | Prosthesis, Upper Femoral | Class II | 21 CFR 888.3360 | 0 | 0 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | Class II | 21 CFR 888.3360 | 59 | 18 |
| JDH | Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal | Class III | 21 CFR 888.3380 | 0 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | 21 CFR 888.3350 | 565 | 255 |
| JDJ | Mesh, Surgical, Acetabular, Hip, Prosthesis | Class II | 21 CFR 878.3300 | 7 | 0 |
| JDK | Prosthesis, Hip, Cement Restrictor | Class II | 21 CFR 878.3300 | 54 | 12 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | Class III | 21 CFR 888.3320 | 45 | 5 |
| JDN | Implant, Fixation Device, Spinal | Class II | 21 CFR 888.3060 | 6 | 0 |
| JDO | Device, Fixation, Proximal Femoral, Implant | Class II | 21 CFR 888.3030 | 23 | 8 |
