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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 60 of 71
FDA product codes, page 60 of 71
CodeDevice nameClassRegulationClearancesRecalls
PPBFoley Catheter Kit (Excludes Hiv Testing)Class II21 CFR 876.5130014
PPCMale External Catheterization Kit (Excludes Hiv Testing)Class II21 CFR 876.513000
PPDUniversal Drainage TrayClass II21 CFR 876.513004
PPENephroscope SetClass II21 CFR 876.150000
PPFUrinary Irrigation KitClass II21 CFR 876.513000
PPGUrinary Drainage Collection KitClass II21 CFR 876.513001
PPHSingle Needle With Uni-Directional Pump KitClass II21 CFR 876.582000
PPIHemodialysis Tray (Not A Start/Stop Kit)Class II21 CFR 876.582000
PPJPeritoneal Dialysis Administration KitClass II21 CFR 876.563000
PPKPeritoneal Dialysis Tubing KitClass II21 CFR 876.563000
PPLSingle Needle (Co-Axial Flow) Dialysis KitClass II21 CFR 876.582000
PPMGeneral Purpose ReagentClass I21 CFR 864.40101630
PPNPercutaneous Catheter, UltrasoundClass II21 CFR 870.1250141
PPOMulti-Lumen Hemodialysis Catheterization KitClass II21 CFR 876.554002
PPPDisposable Joint Aspiration/Injection KitClass I21 CFR 878.480000
PPQTranstibial Anterior Cruciate Ligament KitClass II21 CFR 888.304000
PPRSurgical Cannulaes & Depth Gauge Kit For Arthroscopic ProceduresClass II21 CFR 888.110001
PPSSleeve, Head And Neck, CompressibleClass II21 CFR 870.580010
PPTCranial Surgical Planning And Instrument GuidesClass II21 CFR 882.431040
PPUMicrobial Colony Image Assessment SystemClass II21 CFR 866.219030
PPWAdjunctive Cardiovascular Status IndicatorClass II21 CFR 870.220080
PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection SystemClass II21 CFR 866.3975123
PQCPedicle Screw Placement GuideClass II21 CFR 888.307080
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)Class II21 CFR 862.167501
PQEOstomy Care KitClass I21 CFR 876.590001
PQFSensor, Glucose, Invasive, Non-AdjunctiveClass III04
PQHIodinated Contrast Media Transfer Tubing SetClass II21 CFR 880.544060
PQIWound Retraction And Protection SystemClass II21 CFR 878.437120
PQJIntranasal Electrostimulation DeviceClass II21 CFR 886.530010
PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis AccessClass II21 CFR 870.125271
PQMSurgical Smoke PrecipitatorClass II21 CFR 878.505070
PQNCarbon Dioxide Gas Controlled Tissue ExpanderClass II21 CFR 878.351030
PQOAnti-Müllerian Hormone Test SystemClass II21 CFR 862.109251
PQPNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemClass III018
PQQData Acquisition SoftwareClass II21 CFR 862.257001
PQTAlpha-L-Iduronidase (Idua) Newborn Screening Test SystemClass II21 CFR 862.148800
PQUAlpha-D-Glucosidase (Gaa) Newborn Screening Test SystemClass II21 CFR 862.148800
PQVß-Glucocerebrosidase (Gba) Newborn Screening Test SystemClass II21 CFR 862.148800
PQWAlpha-D-Galactosidase A (Gla) Newborn Screening Test SystemClass II21 CFR 862.148830
PQXEpinephrine SyringeClass II21 CFR 880.586020
PQYNonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of PainClass II21 CFR 890.529020
PQZGbs Culture Media, Selective And DifferentialClass I21 CFR 866.236043
PRAVariola Virus Nucleic Acid-Based Detection AssayClass II21 CFR 866.331610
PRBCervical Intraepithelial Neoplasia (Cin) Test SystemClass II21 CFR 864.186523
PRCDrug-Coated Peripheral Transluminal Angioplasty CatheterClass III01
PRERt-Qpcr Assay For Mrna Transcript Immune BiomarkersClass II21 CFR 866.321540
PRFDocetaxel / Paclitaxel AssayNot classified00
PRHPositive Blood Culture Identification And Ast KitClass II21 CFR 866.165024
PRIProcalcitonin AssayClass II21 CFR 866.321581
PRJCapillary Blood Collection Device For Alternative Site CollectionClass II21 CFR 862.167520
PRKDevice Indicating An Exhalation EventClass II21 CFR 868.237510
PRLIliac Covered Stent, ArterialClass III06
PRMEnteral Administration Kit (Adult & Pediatric)Class II21 CFR 876.598000
PRNPediatric Position HolderClass I21 CFR 880.568000
PROAnti-Regurgitation Blood Tubing KitClass II21 CFR 876.582000
PRPBalloon Gastrostomy Tube KitClass II21 CFR 876.598000
PRQEsophageal Dilator KitClass II21 CFR 876.536500
PRRFeeding Tube KitClass II21 CFR 876.598001
PRSGastric Colonic Catheter Irrigation KitClass II21 CFR 876.598000
PRTGastric Irrigation And Aspiration KitClass II21 CFR 876.598000
PRUGastric Lavage Kit (Adult Or Pediatric Use)Class II21 CFR 876.437000
PRVGastro-Urology Biopsy KitClass II21 CFR 876.107501
PRWGastrointestinal Tube KitClass II21 CFR 876.598000
PRXGastrostomy Guide Wire Placement KitClass II21 CFR 876.598000
PRYGastrostomy Jejunostomy Feeding Tube KitClass II21 CFR 876.598000
PRZGastrostomy Tube KitClass II21 CFR 876.598000
PSALaparoscopic Jejunostomy KitClass II21 CFR 876.598000
PSBNasogastric Feed Tube KitClass II21 CFR 876.598000
PSCNasogastric-Gastrojejunal KitClass II21 CFR 876.598000
PSDLaparoscopic Gastrostomy KitClass II21 CFR 876.598000
PSENeedle Catheter Jejunostomy KitClass II21 CFR 876.598000
PSFNon-Balloon Replacement Gastrostomy SystemClass II21 CFR 876.598000
PSGPercutaneous Endoscopic Gastrostomy KitClass II21 CFR 876.598001
PSHPercutaneous Replacement Gastrostomy Tube KitClass II21 CFR 876.598000
PSIPerineal Irrigation KitClass II21 CFR 876.598000
PSJRectal Dilator KitClass I21 CFR 876.545000
PSKReplacement Gastrostomy Feeding Catheter TrayClass II21 CFR 876.598000
PSL25-Oh-Vitamin D Mass Spectrometry Test SystemClass II21 CFR 862.184010
PSMRefractometer For Donor TestingClass I21 CFR 862.280000
PSNLight Based ImagingClass II21 CFR 878.4580100
PSPIntracranial Pressure & Temperature Monitoring KitClass II21 CFR 882.162001
PSQIntracardiac Patch Or Pledget, Biologically DerivedClass II21 CFR 870.3470112
PSRImplanted Phrenic Nerve Stimulator For Central Sleep ApneaClass III00
PSSMinoxidil Sulfotransferase Or Isoenzymes Test SystemNot classified00
PSTAortic Annuloplasty RingClass II21 CFR 870.380020
PSUJak2 Gene Mutation Detection TestClass II21 CFR 866.607020
PSVUltrasound BronchoscopeClass II21 CFR 892.155042
PSWHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, LiquidClass II21 CFR 892.157070
PSXChlorine MeterClass II21 CFR 876.566510
PSYWhole Slide Imaging SystemClass II21 CFR 864.3700232
PSZDevices Detecting Influenza A, B, And C Virus AntigensClass II21 CFR 866.3328735
PTAGenetic Variant Detection And Health Risk Assessment SystemClass II21 CFR 866.595050
PTBAtaxiagraph With Interpretive SoftwareClass I21 CFR 882.103000
PTCUric Acid Test System For At Home Prescription UseClass I21 CFR 862.177532
PTDSubcutaneous Implanted Apheresis PortClass II21 CFR 880.596530
PTEEndoscopic Morcellator GastroenterologyClass II21 CFR 884.169020
PTFAssay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu AdmissionClass II21 CFR 866.321541
PTGTest, Methadone, Over The CounterClass II21 CFR 862.362000
PTHTest, Barbiturate, Over The CounterClass II21 CFR 862.315010
PTINon-Coring (Huber) NeedleClass II21 CFR 880.55701412