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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
FDA review panels and the number of ingested product codes in each
Review panelPanel codeProduct codes
AnesthesiologyAN262
CardiovascularCV437
Clinical ChemistryCH527
Clinical ToxicologyTX338
DentalDE352
Ear, Nose, ThroatEN269
Gastroenterology, UrologyGU614
General HospitalHO394
General, Plastic SurgerySU562
HematologyHE281
ImmunologyIM278
Medical GeneticsMG7
MicrobiologyMI554
NeurologyNE291
Obstetrics/GynecologyOB269
OphthalmicOP345
OrthopedicOR349
PathologyPA325
Physical MedicinePM210
RadiologyRA216

214 codes carry no review panel in the FDA classification file and appear only in the index below

7,094 product codes, page 61 of 71
FDA product codes, page 61 of 71
CodeDevice nameClassRegulationClearancesRecalls
PTJPhenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured IsolatesClass II21 CFR 866.164031
PTKPediatric Esophageal Atresia Anastomosis DeviceClass III21 CFR 876.598000
PTLWire, Guide, Catheter, ExemptClass II21 CFR 870.133000
PTMSyringe, Balloon Inflation, ExemptClass II21 CFR 870.165007
PTNReservoir, Blood, Cardiopulmonary Bypass, ExemptClass II21 CFR 870.440000
PTOTester, Auditory Impedance, ExemptClass II21 CFR 874.109000
PTPTympanometer, ExemptClass II21 CFR 874.109000
PTQEndoscopic Magnetic Retriever, ExemptClass II21 CFR 876.150000
PTRScissors For Cytoscope, ExemptClass II21 CFR 876.150000
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptClass II21 CFR 876.150000
PTTBiliary Catheter For Irrigation And Contrast Injection, ExemptClass II21 CFR 876.501000
PTUCatheter, Peritoneal, Long-Term Indwelling, ExemptClass II21 CFR 876.563000
PTVCatheter, Peritoneal Dialysis, Single Use, ExemptClass II21 CFR 876.563000
PTWSystem, Peritoneal, Automatic Delivery, ExemptClass II21 CFR 876.563000
PTXSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, ExemptClass II21 CFR 878.449500
PTYComputerized Cognitive Assessment Aid, ExemptClass II21 CFR 882.147000
PTZColposcope (And Colpomicroscope), ExemptClass II21 CFR 884.163000
PUATenaculum, Uterine, ExemptClass II21 CFR 884.453000
PUBAccessory, Assisted Reproduction, ExemptClass II21 CFR 884.612016
PUCMicrotools, Assisted Reproduction (Pipettes), ExemptClass II21 CFR 884.613000
PUDLabware, Assisted Reproduction, ExemptClass II21 CFR 884.616000
PUEBiomicroscope, Slit-Lamp, Ac-Powered, ExemptClass II21 CFR 886.185000
PUFOcular Peg, ExemptClass II21 CFR 886.332000
PUGAnalyzer, Nitrogen Dioxide, ExemptClass II21 CFR 868.238500
PUHAnalyzer, Body Composition, ExemptClass II21 CFR 870.277000
PUIDrape, Surgical, ExemptClass II21 CFR 878.4370041
PUJVoriconazole Test SystemClass II21 CFR 862.397010
PUKAdministration Set Securement DeviceClass I21 CFR 880.521000
PULApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-PoweredClass II21 CFR 886.410040
PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac ProceduresClass II21 CFR 870.125130
PUNLice Removal Kit Containing A SolutionClass I21 CFR 880.596000
PUPEndoscope Maintenance SystemClass II21 CFR 876.150010
PUQMultiplex Flow Immunoassay, T. Gondii, Rubella, Cmv IgmClass II21 CFR 866.351010
PURVacuum SyringeClass II21 CFR 880.586020
PUUTemporary Coil Embolization Assist DeviceClass II21 CFR 882.595510
PUVLymph Node Location System During Sentinel Biopsy ProcedureClass III00
PUWSystem, Test, Radioallergosorbent (Rast) Immunological, Exempt AllergensClass II21 CFR 866.575000
PUXTest, Amphetamine, Employment And Insurance Testing, ExemptClass II21 CFR 862.310000
PUYTest, Barbiturate, Employment And Insurance Testing, ExemptClass II21 CFR 862.315000
PUZTest, Benzodiazepine, Employment And Insurance Testing, ExemptClass II21 CFR 862.317000
PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, ExemptClass II21 CFR 862.325000
PVBTest, Codeine, Employment And Insurance Testing, ExemptClass II21 CFR 862.327000
PVCTest, Lsd, Employment And Insurance Testing, ExemptClass II21 CFR 862.358000
PVDTest, Methamphetamine, Employment And Insurance Testing, ExemptClass II21 CFR 862.361000
PVETest, Methadone, Employment And Insurance Testing, ExemptClass II21 CFR 862.362000
PVFTest, Methaqualone, Employment And Insurance Testing, ExemptClass II21 CFR 862.363000
PVGTest, Morphine, Employment And Insurance Testing, ExemptClass II21 CFR 862.364000
PVHTest, Opiates, Employment And Insurance Testing, ExemptClass II21 CFR 862.365000
PVITest, Propoxyphene, Employment And Insurance Testing, ExemptClass II21 CFR 862.370000
PVJTest, Cannabinoid, Employment And Insurance Testing, ExemptClass II21 CFR 862.387000
PVKTest, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, ExemptClass II21 CFR 862.391000
PVLEndoscopic Shunt Placement KitClass II21 CFR 882.555000
PVMEndoscopic Ventricular Catheter Placement KitClass II21 CFR 882.410000
PVOLumbar Drainage Catheter KitClass II21 CFR 882.555000
PVPNeurological Test KitClass I21 CFR 882.175001
PVQRickettsia Spp. Nucleic Acid Based Detection AssayClass II21 CFR 866.331610
PVRD&C TrayClass II21 CFR 884.453000
PVSFetal Blood Sampling Kit (Excludes Hiv Testing)Class II21 CFR 884.156000
PVTMaternity KitClass I21 CFR 884.543500
PVUObstetrical Anesthesia KitClass II21 CFR 884.510000
PVVParacervical Anesthesia KitClass II21 CFR 884.510000
PVWPudendal Anesthesia KitClass II21 CFR 884.510000
PVXVaginal Examination TrayClass II21 CFR 884.453001
PVYVasovasostomy SetClass I21 CFR 876.473001
PVZNon-Stainless Steel NeedleClass II21 CFR 880.557011
PWABreast Pump Accessory, Milk Expression Aid, Via Positive PressureClass I21 CFR 884.515000
PWBFetal Head ElevatorClass II21 CFR 884.435020
PWCGeneral Wellness ProductNot classified03
PWDFlow Cytometric Test System For Hematopoietic NeoplasmsClass II21 CFR 864.701020
PWEComputerized Behavioral Therapy Device For Substance Use DisordersClass II21 CFR 882.580122
PWGSpinal Fixation SystemNot classified00
PWHAdministrations Sets With Neuraxial ConnectorsClass II21 CFR 880.544040
PWIInstrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ ProlapseClass II21 CFR 884.4910213
PWJInstrumentation, Surgical Mesh, Urogynecologic, Stress Urinary IncontinenceClass II21 CFR 884.491050
PWKInstrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ ProlapseClass II21 CFR 884.491010
PWLOral Surgery TrayClass I21 CFR 872.4565015
PWMAdmission Kit (Patient Utensil)Class I21 CFR 880.673000
PWNBaby Care KitClass II21 CFR 880.570000
PWOBlood Administration KitClass II21 CFR 880.544000
PWPBlood Borne Pathogen Response KitClass I21 CFR 880.625000
PWQBuret Administration Intravenous KitClass II21 CFR 880.544000
PWRCatheter Repair KitClass II21 CFR 880.597001
PWSChemotherapy Administration KitClass I21 CFR 880.625000
PWTChemotherapy Spill Clean-Up KitClass I21 CFR 880.625000
PWUClean-Up KitClass I21 CFR 880.689000
PWVDelivery Room Apparel KitClass I21 CFR 880.625000
PWWFever Monitoring KitClass II21 CFR 880.291000
PWXInsect Sting Emergency KitClass I21 CFR 880.574000
PWYLumbar Puncture Tray (Adult & Pediatric)Class II21 CFR 880.5570021
PWZMid-Stream Collection KitClass I21 CFR 880.673000
PXAOral Administration SetClass I21 CFR 880.643000
PXBPercutaneous Introducer KitClass II21 CFR 880.557001
PXCPersonal Protection KitClass I21 CFR 880.625001
PXDPrep KitClass I21 CFR 880.625000
PXEPressure Monitoring (Air/Gas) KitClass I21 CFR 868.261000
PXFSitz Bath KitClass I21 CFR 880.673000
PXGSpill KitClass I21 CFR 880.689000
PXHThermometer KitClass II21 CFR 880.291000
PXIThoracentesis TrayClass II21 CFR 880.5570019
PXJUmbilical Catheter Insertion TrayClass II21 CFR 880.520000