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 |
|---|---|---|---|---|---|
| JNE | Glucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase | Class I | 21 CFR 862.1570 | 0 | 0 |
| JNF | Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen | Class I | 21 CFR 862.1590 | 1 | 0 |
| JNG | Radioimmunoassay, Pregnenolone | Class I | 21 CFR 862.1615 | 0 | 0 |
| JNJ | Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase | Class I | 21 CFR 862.1650 | 0 | 0 |
| JNK | Beta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase | Class I | 21 CFR 862.1670 | 0 | 0 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | Class II | 21 CFR 866.5870 | 22 | 4 |
| JNM | Immunochemical, Transferrin | Class II | 21 CFR 866.5880 | 3 | 3 |
| JNN | P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | Class I | 21 CFR 862.1725 | 0 | 0 |
| JNO | N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin | Class I | 21 CFR 862.1725 | 7 | 2 |
| JNP | Infrared Spectroscopy Measurement, Urinary Calculi (Stone) | Class I | 21 CFR 862.1780 | 0 | 0 |
| JNQ | Qualitative Chemical Reactions, Urinary Calculi (Stone) | Class I | 21 CFR 862.1780 | 0 | 0 |
| JNS | Stannous Chloride - Hydrazine, Phospholipids | Class I | 21 CFR 862.1575 | 0 | 0 |
| JNT | Chromatographic, Phospholipids | Class I | 21 CFR 862.1575 | 3 | 0 |
| JNX | Membrane Osmometry, Plasma Oncometry | Class I | 21 CFR 862.1530 | 0 | 0 |
| JNY | Glyceralde-3-Phosphate, Nadh (Enzymatic), Triose Phosphate Isomerase | Class I | 21 CFR 862.1720 | 0 | 0 |
| JNZ | Fluorometric, Uroporphyrin | Class I | 21 CFR 862.1790 | 0 | 0 |
| JOA | Acid, Trifluoroacetic, Vitamin A, Hexane Extraction | Class I | 21 CFR 862.1805 | 0 | 0 |
| JOB | Hexane Extraction, Fluorescence, Vitamin E | Class I | 21 CFR 862.1815 | 1 | 0 |
| JOC | Colorimetric, Xylose | Class I | 21 CFR 862.1820 | 1 | 0 |
| JOD | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass | Class II | 21 CFR 870.4270 | 12 | 0 |
| JOF | Polymer, Ent Synthetic, Porous Polyethylene | Class II | 21 CFR 874.3620 | 6 | 0 |
| JOH | Tube Tracheostomy And Tube Cuff | Class II | 21 CFR 868.5800 | 109 | 131 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | Class II | 21 CFR 880.2800 | 265 | 24 |
| JOK | Scissors, Medical, Disposable | Class I | 21 CFR 880.6820 | 7 | 3 |
| JOL | Catheter And Tip, Suction | Class II | 21 CFR 880.6740 | 84 | 16 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | Class II | 21 CFR 870.2780 | 53 | 0 |
| JON | Transducer, Apex Cardiographic | Class II | 21 CFR 870.2840 | 0 | 0 |
| JOO | Transducer, Heart Sound | Class II | 21 CFR 870.2860 | 0 | 0 |
| JOP | Transducer, Ultrasonic | Class II | 21 CFR 870.2880 | 72 | 1 |
| JOQ | Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | Class II | 21 CFR 870.1750 | 18 | 3 |
| JOR | Generator, Pulsatile Flow, Cardiopulmonary Bypass | Class III | 21 CFR 870.4320 | 0 | 2 |
| JOS | Electrode, Electrosurgical | Class II | 21 CFR 878.4400 | 36 | 9 |
| JOT | Electrode, Gel, Electrosurgical | Class II | 21 CFR 878.4400 | 9 | 0 |
| JOW | Sleeve, Limb, Compressible | Class II | 21 CFR 870.5800 | 354 | 32 |
| JOX | Analyzer, Heparin, Automated | Class II | 21 CFR 864.5680 | 15 | 2 |
| JOY | Device, Automated Cell-Locating | Class II | 21 CFR 864.5260 | 35 | 4 |
| JOZ | System, Automated Platelet Aggregation | Class II | 21 CFR 864.5700 | 38 | 11 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | Class II | 21 CFR 864.5425 | 181 | 43 |
| JPB | Hemoglobin M | Class II | 21 CFR 864.7415 | 0 | 2 |
| JPC | Hemoglobin F Quantitation | Class II | 21 CFR 864.7455 | 1 | 0 |
| JPD | Hemoglobin A2 Quantitation | Class II | 21 CFR 864.7400 | 13 | 5 |
| JPE | Antithrombin Iii, Two Stage Clotting Time Assay | Class II | 21 CFR 864.7060 | 1 | 0 |
| JPF | Prothrombin-Proconvertin And Thrombotest | Class II | 21 CFR 864.7735 | 0 | 1 |
| JPH | Test, Erythrocyte Sedimentation Rate | Class I | 21 CFR 864.6700 | 7 | 0 |
| JPI | Device, Hematocrit Measuring | Class II | 21 CFR 864.6400 | 15 | 9 |
| JPJ | Red-Cell Indices, Calculated | Class II | 21 CFR 864.5300 | 3 | 0 |
| JPK | Mixture, Hematology Quality Control | Class II | 21 CFR 864.8625 | 192 | 16 |
| JPW | Pump, Nebulizer, Electrically Powered | Class I | 21 CFR 874.5220 | 1 | 0 |
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | Class I | 21 CFR 862.1360 | 33 | 0 |
| JQA | Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes | Class I | 21 CFR 862.1360 | 0 | 2 |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | Class I | 21 CFR 862.1360 | 52 | 0 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class I | 21 CFR 862.2050 | 38 | 16 |
| JQD | Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity | Class I | 21 CFR 862.1415 | 0 | 0 |
| JQE | Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity | Class I | 21 CFR 862.1415 | 6 | 0 |
| JQF | Bathophenanthroline, Iron Binding Capacity | Class I | 21 CFR 862.1415 | 8 | 0 |
| JQG | Radiometric, Fe59, Iron Binding Capacity | Class I | 21 CFR 862.1415 | 5 | 0 |
| JQH | Trinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen) | Class I | 21 CFR 862.1515 | 0 | 0 |
| JQI | Rotating Disc, Plasma Viscometry | Class I | 21 CFR 862.1475 | 0 | 0 |
| JQJ | Densitometeric, Protein Fractionation | Class I | 21 CFR 862.1630 | 1 | 0 |
| JQK | Immunodiffusion, Protein Fractionation | Class I | 21 CFR 862.1630 | 1 | 0 |
| JQL | Spectrophotometric, Uroporphyrin | Class I | 21 CFR 862.1790 | 0 | 0 |
| JQM | P-Bromoaniline, Xylose | Class I | 21 CFR 862.1820 | 0 | 0 |
| JQN | Colorimetric, Mucopolysaccharides | Class I | 21 CFR 862.1505 | 2 | 0 |
| JQO | Balance, Analytical | Class I | 21 CFR 862.2050 | 0 | 0 |
| JQP | Calculator/Data Processing Module, For Clinical Use | Class I | 21 CFR 862.2100 | 78 | 218 |
| JQQ | Dialyzer | Class I | 21 CFR 862.2050 | 1 | 0 |
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | Class I | 21 CFR 862.2400 | 18 | 0 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | Class I | 21 CFR 862.2750 | 140 | 36 |
| JQX | Nephelometer, For Clinical Use | Class I | 21 CFR 862.2700 | 14 | 4 |
| JQY | Ph Meter | Class I | 21 CFR 862.2050 | 8 | 0 |
| JQZ | Polarimeter | Class I | 21 CFR 862.2050 | 1 | 0 |
| JRA | Microtitrator, For Clinical Use | Class I | 21 CFR 862.2680 | 1 | 0 |
| JRB | Micro Mixer | Class I | 21 CFR 862.2050 | 0 | 1 |
| JRC | Micro Pipette | Class I | 21 CFR 862.2050 | 6 | 3 |
| JRE | Refractometer For Clinical Use | Class I | 21 CFR 862.2800 | 13 | 0 |
| JRG | Block, Heating | Class I | 21 CFR 862.2050 | 3 | 0 |
| JRI | Cuvette, Thermostated | Class I | 21 CFR 862.2050 | 4 | 0 |
| JRJ | Unit, Drying | Class I | 21 CFR 862.2050 | 1 | 3 |
| JRK | Evaporator | Class I | 21 CFR 862.2050 | 0 | 0 |
| JRL | Unit, Filter, Membrane | Class I | 21 CFR 862.2050 | 9 | 0 |
| JRM | Freezer | Class I | 21 CFR 862.2050 | 7 | 1 |
| JRO | Blender/Mixer | Class I | 21 CFR 862.2050 | 0 | 0 |
| JRQ | Shaker/Stirrer | Class I | 21 CFR 862.2050 | 8 | 0 |
| JRR | Regulator, Temperature | Class I | 21 CFR 862.2050 | 4 | 0 |
| JRS | Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | Class I | 21 CFR 862.2050 | 0 | 0 |
| JRW | Antisera, Fluorescent, B. Parapertussis | Class I | 21 CFR 866.3065 | 2 | 0 |
| JRY | Antiserum, Fluorescent, Epstein-Barr Virus | Class I | 21 CFR 866.3235 | 9 | 0 |
| JRZ | Media, Culture, Amino Acid Assay | Class I | 21 CFR 866.2350 | 0 | 0 |
| JSA | Culture Media, Antibiotic Assay | Class I | 21 CFR 866.2350 | 8 | 0 |
| JSB | Culture Media, Vitamin Assay | Class I | 21 CFR 866.2350 | 0 | 0 |
| JSC | Culture Media, General Nutrient Broth | Class I | 21 CFR 866.2350 | 52 | 5 |
| JSD | Culture Media, Selective Broth | Class I | 21 CFR 866.2360 | 26 | 2 |
| JSE | Culture Media, Multiple Biochemical Test | Class I | 21 CFR 866.2320 | 53 | 0 |
| JSF | Culture Media, Single Biochemical Test | Class I | 21 CFR 866.2320 | 87 | 0 |
| JSG | Culture Media, Non-Selective And Non-Differential | Class I | 21 CFR 866.2300 | 209 | 29 |
| JSH | Culture Media, Non-Selective And Differential | Class I | 21 CFR 866.2320 | 146 | 2 |
| JSI | Culture Media, Selective And Differential | Class I | 21 CFR 866.2360 | 285 | 24 |
| JSJ | Culture Media, Selective And Non-Differential | Class I | 21 CFR 866.2360 | 307 | 6 |
| JSK | Supplement, Culture Media | Class I | 21 CFR 866.2450 | 70 | 6 |
| JSL | Culture Media, Anaerobic Transport | Class I | 21 CFR 866.2390 | 8 | 0 |
