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 |
|---|---|---|---|---|---|
| PTJ | Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates | Class II | 21 CFR 866.1640 | 3 | 1 |
| PTK | Pediatric Esophageal Atresia Anastomosis Device | Class III | 21 CFR 876.5980 | 0 | 0 |
| PTL | Wire, Guide, Catheter, Exempt | Class II | 21 CFR 870.1330 | 0 | 0 |
| PTM | Syringe, Balloon Inflation, Exempt | Class II | 21 CFR 870.1650 | 0 | 7 |
| PTN | Reservoir, Blood, Cardiopulmonary Bypass, Exempt | Class II | 21 CFR 870.4400 | 0 | 0 |
| PTO | Tester, Auditory Impedance, Exempt | Class II | 21 CFR 874.1090 | 0 | 0 |
| PTP | Tympanometer, Exempt | Class II | 21 CFR 874.1090 | 0 | 0 |
| PTQ | Endoscopic Magnetic Retriever, Exempt | Class II | 21 CFR 876.1500 | 0 | 0 |
| PTR | Scissors For Cytoscope, Exempt | Class II | 21 CFR 876.1500 | 0 | 0 |
| PTS | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Class II | 21 CFR 876.1500 | 0 | 0 |
| PTT | Biliary Catheter For Irrigation And Contrast Injection, Exempt | Class II | 21 CFR 876.5010 | 0 | 0 |
| PTU | Catheter, Peritoneal, Long-Term Indwelling, Exempt | Class II | 21 CFR 876.5630 | 0 | 0 |
| PTV | Catheter, Peritoneal Dialysis, Single Use, Exempt | Class II | 21 CFR 876.5630 | 0 | 0 |
| PTW | System, Peritoneal, Automatic Delivery, Exempt | Class II | 21 CFR 876.5630 | 0 | 0 |
| PTX | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt | Class II | 21 CFR 878.4495 | 0 | 0 |
| PTY | Computerized Cognitive Assessment Aid, Exempt | Class II | 21 CFR 882.1470 | 0 | 0 |
| PTZ | Colposcope (And Colpomicroscope), Exempt | Class II | 21 CFR 884.1630 | 0 | 0 |
| PUA | Tenaculum, Uterine, Exempt | Class II | 21 CFR 884.4530 | 0 | 0 |
| PUB | Accessory, Assisted Reproduction, Exempt | Class II | 21 CFR 884.6120 | 1 | 6 |
| PUC | Microtools, Assisted Reproduction (Pipettes), Exempt | Class II | 21 CFR 884.6130 | 0 | 0 |
| PUD | Labware, Assisted Reproduction, Exempt | Class II | 21 CFR 884.6160 | 0 | 0 |
| PUE | Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | Class II | 21 CFR 886.1850 | 0 | 0 |
| PUF | Ocular Peg, Exempt | Class II | 21 CFR 886.3320 | 0 | 0 |
| PUG | Analyzer, Nitrogen Dioxide, Exempt | Class II | 21 CFR 868.2385 | 0 | 0 |
| PUH | Analyzer, Body Composition, Exempt | Class II | 21 CFR 870.2770 | 0 | 0 |
| PUI | Drape, Surgical, Exempt | Class II | 21 CFR 878.4370 | 0 | 41 |
| PUJ | Voriconazole Test System | Class II | 21 CFR 862.3970 | 1 | 0 |
| PUK | Administration Set Securement Device | Class I | 21 CFR 880.5210 | 0 | 0 |
| PUL | Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered | Class II | 21 CFR 886.4100 | 4 | 0 |
| PUM | Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures | Class II | 21 CFR 870.1251 | 3 | 0 |
| PUN | Lice Removal Kit Containing A Solution | Class I | 21 CFR 880.5960 | 0 | 0 |
| PUP | Endoscope Maintenance System | Class II | 21 CFR 876.1500 | 1 | 0 |
| PUQ | Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm | Class II | 21 CFR 866.3510 | 1 | 0 |
| PUR | Vacuum Syringe | Class II | 21 CFR 880.5860 | 2 | 0 |
| PUU | Temporary Coil Embolization Assist Device | Class II | 21 CFR 882.5955 | 1 | 0 |
| PUV | Lymph Node Location System During Sentinel Biopsy Procedure | Class III | 0 | 0 | |
| PUW | System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens | Class II | 21 CFR 866.5750 | 0 | 0 |
| PUX | Test, Amphetamine, Employment And Insurance Testing, Exempt | Class II | 21 CFR 862.3100 | 0 | 0 |
| PUY | Test, Barbiturate, Employment And Insurance Testing, Exempt | Class II | 21 CFR 862.3150 | 0 | 0 |
| PUZ | Test, Benzodiazepine, Employment And Insurance Testing, Exempt | Class II | 21 CFR 862.3170 | 0 | 0 |
| PVA | Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | Class II | 21 CFR 862.3250 | 0 | 0 |
| PVB | Test, Codeine, Employment And Insurance Testing, Exempt | Class II | 21 CFR 862.3270 | 0 | 0 |
| PVC | Test, Lsd, Employment And Insurance Testing, Exempt | Class II | 21 CFR 862.3580 | 0 | 0 |
| PVD | Test, Methamphetamine, Employment And Insurance Testing, Exempt | Class II | 21 CFR 862.3610 | 0 | 0 |
| PVE | Test, Methadone, Employment And Insurance Testing, Exempt | Class II | 21 CFR 862.3620 | 0 | 0 |
| PVF | Test, Methaqualone, Employment And Insurance Testing, Exempt | Class II | 21 CFR 862.3630 | 0 | 0 |
| PVG | Test, Morphine, Employment And Insurance Testing, Exempt | Class II | 21 CFR 862.3640 | 0 | 0 |
| PVH | Test, Opiates, Employment And Insurance Testing, Exempt | Class II | 21 CFR 862.3650 | 0 | 0 |
| PVI | Test, Propoxyphene, Employment And Insurance Testing, Exempt | Class II | 21 CFR 862.3700 | 0 | 0 |
| PVJ | Test, Cannabinoid, Employment And Insurance Testing, Exempt | Class II | 21 CFR 862.3870 | 0 | 0 |
| PVK | Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt | Class II | 21 CFR 862.3910 | 0 | 0 |
| PVL | Endoscopic Shunt Placement Kit | Class II | 21 CFR 882.5550 | 0 | 0 |
| PVM | Endoscopic Ventricular Catheter Placement Kit | Class II | 21 CFR 882.4100 | 0 | 0 |
| PVO | Lumbar Drainage Catheter Kit | Class II | 21 CFR 882.5550 | 0 | 0 |
| PVP | Neurological Test Kit | Class I | 21 CFR 882.1750 | 0 | 1 |
| PVQ | Rickettsia Spp. Nucleic Acid Based Detection Assay | Class II | 21 CFR 866.3316 | 1 | 0 |
| PVR | D&C Tray | Class II | 21 CFR 884.4530 | 0 | 0 |
| PVS | Fetal Blood Sampling Kit (Excludes Hiv Testing) | Class II | 21 CFR 884.1560 | 0 | 0 |
| PVT | Maternity Kit | Class I | 21 CFR 884.5435 | 0 | 0 |
| PVU | Obstetrical Anesthesia Kit | Class II | 21 CFR 884.5100 | 0 | 0 |
| PVV | Paracervical Anesthesia Kit | Class II | 21 CFR 884.5100 | 0 | 0 |
| PVW | Pudendal Anesthesia Kit | Class II | 21 CFR 884.5100 | 0 | 0 |
| PVX | Vaginal Examination Tray | Class II | 21 CFR 884.4530 | 0 | 1 |
| PVY | Vasovasostomy Set | Class I | 21 CFR 876.4730 | 0 | 1 |
| PVZ | Non-Stainless Steel Needle | Class II | 21 CFR 880.5570 | 1 | 1 |
| PWA | Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | Class I | 21 CFR 884.5150 | 0 | 0 |
| PWB | Fetal Head Elevator | Class II | 21 CFR 884.4350 | 2 | 0 |
| PWC | General Wellness Product | Not classified | 0 | 3 | |
| PWD | Flow Cytometric Test System For Hematopoietic Neoplasms | Class II | 21 CFR 864.7010 | 2 | 0 |
| PWE | Computerized Behavioral Therapy Device For Substance Use Disorders | Class II | 21 CFR 882.5801 | 2 | 2 |
| PWG | Spinal Fixation System | Not classified | 0 | 0 | |
| PWH | Administrations Sets With Neuraxial Connectors | Class II | 21 CFR 880.5440 | 4 | 0 |
| PWI | Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse | Class II | 21 CFR 884.4910 | 2 | 13 |
| PWJ | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence | Class II | 21 CFR 884.4910 | 5 | 0 |
| PWK | Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse | Class II | 21 CFR 884.4910 | 1 | 0 |
| PWL | Oral Surgery Tray | Class I | 21 CFR 872.4565 | 0 | 15 |
| PWM | Admission Kit (Patient Utensil) | Class I | 21 CFR 880.6730 | 0 | 0 |
| PWN | Baby Care Kit | Class II | 21 CFR 880.5700 | 0 | 0 |
| PWO | Blood Administration Kit | Class II | 21 CFR 880.5440 | 0 | 0 |
| PWP | Blood Borne Pathogen Response Kit | Class I | 21 CFR 880.6250 | 0 | 0 |
| PWQ | Buret Administration Intravenous Kit | Class II | 21 CFR 880.5440 | 0 | 0 |
| PWR | Catheter Repair Kit | Class II | 21 CFR 880.5970 | 0 | 1 |
| PWS | Chemotherapy Administration Kit | Class I | 21 CFR 880.6250 | 0 | 0 |
| PWT | Chemotherapy Spill Clean-Up Kit | Class I | 21 CFR 880.6250 | 0 | 0 |
| PWU | Clean-Up Kit | Class I | 21 CFR 880.6890 | 0 | 0 |
| PWV | Delivery Room Apparel Kit | Class I | 21 CFR 880.6250 | 0 | 0 |
| PWW | Fever Monitoring Kit | Class II | 21 CFR 880.2910 | 0 | 0 |
| PWX | Insect Sting Emergency Kit | Class I | 21 CFR 880.5740 | 0 | 0 |
| PWY | Lumbar Puncture Tray (Adult & Pediatric) | Class II | 21 CFR 880.5570 | 0 | 21 |
| PWZ | Mid-Stream Collection Kit | Class I | 21 CFR 880.6730 | 0 | 0 |
| PXA | Oral Administration Set | Class I | 21 CFR 880.6430 | 0 | 0 |
| PXB | Percutaneous Introducer Kit | Class II | 21 CFR 880.5570 | 0 | 1 |
| PXC | Personal Protection Kit | Class I | 21 CFR 880.6250 | 0 | 1 |
| PXD | Prep Kit | Class I | 21 CFR 880.6250 | 0 | 0 |
| PXE | Pressure Monitoring (Air/Gas) Kit | Class I | 21 CFR 868.2610 | 0 | 0 |
| PXF | Sitz Bath Kit | Class I | 21 CFR 880.6730 | 0 | 0 |
| PXG | Spill Kit | Class I | 21 CFR 880.6890 | 0 | 0 |
| PXH | Thermometer Kit | Class II | 21 CFR 880.2910 | 0 | 0 |
| PXI | Thoracentesis Tray | Class II | 21 CFR 880.5570 | 0 | 19 |
| PXJ | Umbilical Catheter Insertion Tray | Class II | 21 CFR 880.5200 | 0 | 0 |
