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 |
|---|---|---|---|---|---|
| NWG | Autoantibodies, Glutamic Acid Decarboxylase (Gad) | Class II | 21 CFR 866.5660 | 2 | 0 |
| NWI | Electrosurgical Electrode Kit | Class II | 21 CFR 876.4300 | 0 | 1 |
| NWJ | Suture, Recombinant Technology | Class II | 21 CFR 878.4494 | 9 | 1 |
| NWM | Immunoassay, Anti-Seizure Drug | Class II | 21 CFR 862.3350 | 5 | 0 |
| NWN | Laparoscopic Bone Anchor Urethropexy Instrument Kit | Class II | 21 CFR 888.3040 | 0 | 1 |
| NWO | Kit, Catheter, Urinary (Exludes Hiv Testing) | Class II | 21 CFR 876.5130 | 1 | 3 |
| NWP | Suprapubic Cystostomy Catheter Kit | Class II | 21 CFR 876.5090 | 0 | 0 |
| NWS | Kit, Choledochoscope, Flexible And Rigid | Class II | 21 CFR 876.1500 | 1 | 0 |
| NWT | Endoscopic Cholangiogram Kit | Class II | 21 CFR 876.1500 | 0 | 0 |
| NWU | Endoscope Introducer Kit | Class II | 21 CFR 876.1500 | 3 | 25 |
| NWV | Laparoscopic Accessories, Gynecologic | Class I | 21 CFR 884.1720 | 0 | 7 |
| NWW | Hysteroscope Accessories | Class I | 21 CFR 884.1690 | 0 | 0 |
| NWX | Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring | Class III | 0 | 3 | |
| NWY | Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies | Not classified | 0 | 2 | |
| NWZ | Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids | Class II | 21 CFR 866.3045 | 1 | 0 |
| NXA | Tracheotomy Care Kit | Class II | 21 CFR 868.5800 | 1 | 12 |
| NXB | Dispenser, Solid Medication | Class I | 21 CFR 890.5050 | 3 | 1 |
| NXC | Aligner, Sequential | Class II | 21 CFR 872.5470 | 145 | 2 |
| NXD | Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna | Class II | 21 CFR 866.3332 | 3 | 0 |
| NXE | Walker, Mechanical, Poly Vinyl Chloride (Pvc) | Class I | 21 CFR 890.3825 | 1 | 0 |
| NXF | Gas, Laser Generating | Class I | 21 CFR 878.4810 | 0 | 0 |
| NXG | Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion | Class III | 0 | 0 | |
| NXH | Nursing Pad, Cohesive Gel | Class I | 21 CFR 880.5630 | 1 | 0 |
| NXJ | Denture, Cosmetic Only | Not classified | 0 | 0 | |
| NXM | Prosthesis, Eyelid Spacer/Graft, Biologic | Class II | 21 CFR 886.3130 | 2 | 0 |
| NXO | Calprotectin, Fecal | Class II | 21 CFR 866.5180 | 15 | 3 |
| NXQ | Reminder, Medication | Class I | 21 CFR 890.5050 | 2 | 1 |
| NXR | Fixation, Vision Training, Binocular | Class I | 21 CFR 886.1290 | 1 | 0 |
| NXT | Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing | Class III | 0 | 6 | |
| NXV | Diagnostic Light, Soft Tissue Detector | Class II | 21 CFR 872.6350 | 12 | 0 |
| NXW | Scaffold, Infrapopliteal, Absorbable | Class III | 0 | 0 | |
| NXX | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus | Class I | 21 CFR 866.3700 | 4 | 1 |
| NXZ | Dental Hygiene Kit | Class I | 21 CFR 872.6855 | 0 | 0 |
| NYC | Dental Prophylaxis Kit | Class I | 21 CFR 872.4565 | 0 | 0 |
| NYD | Endodontic Kit | Class II | 21 CFR 872.3820 | 0 | 1 |
| NYE | Fixture Mount Kit | Class I | 21 CFR 872.3980 | 0 | 0 |
| NYF | Gingival Retraction Kit | Class I | 21 CFR 872.4565 | 0 | 0 |
| NYG | Lapping Tool Kit | Class I | 21 CFR 872.4565 | 0 | 0 |
| NYH | Plaque Disclosing Kit | Class II | 21 CFR 872.1740 | 1 | 0 |
| NYI | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer | Class II | 21 CFR 866.6040 | 10 | 1 |
| NYK | Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma) | Class II | 21 CFR 886.1385 | 1 | 0 |
| NYL | Handpiece, Air-Powered, Root Canal Irrigation | Class I | 21 CFR 872.4200 | 5 | 0 |
| NYN | Stimulator, Electrical, Transcutaneous, For Arthritis | Class II | 21 CFR 882.5890 | 8 | 0 |
| NYO | Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody | Class II | 21 CFR 866.5100 | 4 | 0 |
| NYQ | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer | Class II | 21 CFR 864.1890 | 0 | 6 |
| NYS | Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac) | Class II | 21 CFR 878.4015 | 1 | 0 |
| NYT | Prosthesis, Tracheal, Expandable, Polymeric | Class II | 21 CFR 878.3720 | 3 | 0 |
| NYU | Catheter, Hemodialysis, Implanted, Coated | Class II | 21 CFR 876.5540 | 2 | 30 |
| NYV | Gastrointestinal Motility System, Capsule | Class II | 21 CFR 876.1725 | 5 | 0 |
| NYW | Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief | Class II | 21 CFR 882.5890 | 0 | 0 |
| NYX | Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes | Class II | 21 CFR 882.5890 | 0 | 0 |
| NYY | Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation | Class II | 21 CFR 890.5850 | 0 | 0 |
| NYZ | Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning | Class II | 21 CFR 890.5850 | 0 | 0 |
| NZA | Accessories, Germicide, Cleaning, For Endoscopes | Class II | 21 CFR 876.1500 | 11 | 1 |
| NZB | Quality Control Material, Genetics, Dna | Class II | 21 CFR 866.5910 | 4 | 0 |
| NZC | Stent, Urethral, Prostatic, Semi-Permanent | Class III | 0 | 0 | |
| NZD | Stretcher, Patient Restraint | Class I | 21 CFR 880.6900 | 1 | 2 |
| NZE | Hyperthermia Monitor | Class II | 21 CFR 870.5900 | 6 | 1 |
| NZF | Static Electricity-Emitting Device, Cosmetic Use | Not classified | 0 | 0 | |
| NZG | Bassinet, Hospital | Class II | 21 CFR 880.5145 | 0 | 2 |
| NZH | Medication Management System, Remote | Class II | 21 CFR 880.6315 | 2 | 0 |
| NZJ | Respirator, N95, For Use By The General Public In Public Health Medical Emergencies | Class II | 21 CFR 880.6260 | 2 | 2 |
| NZK | Stimulator, Low Electric Field, Tumor Treatment | Class III | 0 | 0 | |
| NZP | Sealant, Microbial | Class II | 21 CFR 878.4370 | 4 | 0 |
| NZS | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast | Class I | 21 CFR 866.2660 | 3 | 0 |
| NZT | Dosimeter, Ionizing Radiation, Implanted | Class II | 21 CFR 892.5050 | 7 | 5 |
| NZU | Collector, Urine, Powered, Non Indwelling Catheter | Class I | 21 CFR 876.5250 | 1 | 1 |
| NZW | Heparin, Vascular Access Flush | Class II | 21 CFR 880.5200 | 7 | 44 |
| NZX | Water, Vascular Access Flush | Class II | 21 CFR 880.5200 | 0 | 0 |
| NZY | Light, Lymphedema Reduction, Low Energy | Class II | 21 CFR 890.5500 | 1 | 0 |
| OAA | Aid, Visual, For Nausea | Not classified | 0 | 0 | |
| OAB | Low Energy Direct Current Thermal Ablation System | Class II | 21 CFR 878.4400 | 15 | 4 |
| OAC | Plethysmograph, Air Displacement For Body Composition Analysis | Class II | 21 CFR 870.2770 | 3 | 0 |
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | Class III | 0 | 22 | |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Class III | 0 | 34 | |
| OAF | Implant, Hearing, Active, Middle Ear, Totally Implanted | Class III | 0 | 2 | |
| OAG | Garment, Storage, Peritoneal Dialysis Catheter | Class I | 21 CFR 890.5050 | 0 | 0 |
| OAH | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis | Class I | 21 CFR 866.3740 | 4 | 1 |
| OAI | Assay, Enterovirus Nucleic Acid | Class II | 21 CFR 866.3225 | 2 | 0 |
| OAJ | Catheter, Drainage, Intraoral/Extraoral | Class I | 21 CFR 878.4200 | 1 | 0 |
| OAL | Exercise Equipment, Powered, Emg-Triggered | Class II | 21 CFR 890.1375 | 1 | 0 |
| OAM | Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | Class I | 21 CFR 862.1550 | 2 | 1 |
| OAN | Orthosis, Cranial, Laser Scan | Class II | 21 CFR 882.5970 | 23 | 0 |
| OAO | Cord Blood Processing System And Storage Container | Class II | 21 CFR 864.9900 | 0 | 0 |
| OAP | Laser, Comb, Hair | Class II | 21 CFR 890.5500 | 114 | 1 |
| OAQ | Electronic Media, Hyperacusis | Not classified | 0 | 0 | |
| OAR | Injector, Vertebroplasty (Does Not Contain Cement) | Class I | 21 CFR 888.4200 | 1 | 26 |
| OAS | X-Ray, Tomography, Computed, Dental | Class II | 21 CFR 892.1750 | 135 | 7 |
| OAT | Implant, Endosseous, Orthodontic | Class II | 21 CFR 872.3640 | 52 | 3 |
| OAU | Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma | Class II | 21 CFR 866.6030 | 1 | 0 |
| OAV | Mycophenolic Acid Test System | Class II | 21 CFR 862.3840 | 3 | 0 |
| OAW | Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma | Humanitarian device exemption | 0 | 1 | |
| OAX | Plasmodium Spp. Detection Reagents | Class II | 21 CFR 866.3402 | 1 | 0 |
| OAY | Light Source System, Diagnostic Endoscopic | Class III | 0 | 1 | |
| OAZ | One-Way Air-Leak Valve | Humanitarian device exemption | 0 | 0 | |
| OBA | Polymerizing, Neurovascular Embolization Material | Humanitarian device exemption | 0 | 0 | |
| OBB | Kit, Conception-Assist, Home Use | Class II | 21 CFR 884.5250 | 4 | 0 |
| OBC | Occluder, Internal Vessel, Temporary | Class III | 0 | 18 | |
| OBD | Barrier, Adhesion, Cardiovascular | Class III | 0 | 0 | |
| OBE | Anti-Ss-A 52 Autoantibodies | Class II | 21 CFR 866.5100 | 3 | 0 |
