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 2026-10-05, 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 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

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

7,094 product codes, page 58 of 71

FDA product codes, page 58 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
PFM	Hemibridge System	Not classified		0	0
PFN	Implanted Brain Stimulator For Epilepsy	Class III		0	0
PFO	Active Implantable Bone Conduction Hearing System	Class II	21 CFR 874.3340	12	0
PFP	Silicone Hydrogel For Scar Management	Class I	21 CFR 878.4025	1	0
PFQ	Mmp-9 Test System	Class I	21 CFR 862.1540	1	3
PFR	System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection	Class II	21 CFR 866.5900	1	0
PFS	System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection	Class II	21 CFR 866.5900	1	2
PFT	Reagents For Molecular Diagnostic Test Systems	Class I	21 CFR 862.3800	1	2
PFU	Tissue Processing Kit	Not classified		0	0
PFV	System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment	Class III		0	1
PFW	Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat	Class II	21 CFR 890.5300	9	0
PFX	System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection	Class II	21 CFR 866.5920	2	2
PFY	Low Patient Acuity Monitoring System	Class II	21 CFR 870.2300	0	0
PFZ	Ophthalmic Sealant	Class III		0	0
PGD	Colon Capsule Imaging System	Class II	21 CFR 876.1330	2	0
PGE	Gastric Emptying Breath Test	Class III		0	1
PGH	Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel	Class II	21 CFR 866.3307	3	1
PGI	Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples	Class II	21 CFR 866.3309	9	2
PGJ	Oximeter, Wellness	Class II	21 CFR 870.2700	0	0
PGK	Cannula, Injector, Uterine, Endometrial Biopsy	Class II	21 CFR 884.4530	2	0
PGM	Growing Rod System	Class II	21 CFR 888.3070	14	0
PGN	Growing Rod System- Magnetic Actuation	Class II	21 CFR 888.3070	9	4
PGO	Anti-Stick Glass Syringe	Not classified		0	0
PGQ	Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification	Class III		0	3
PGT	Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar	Class II	21 CFR 884.1710	3	0
PGU	Spatial Imaging For Display Of Endoscope Position	Class II	21 CFR 876.1500	1	0
PGV	Anti-Phospholipase A2 Receptor	Class II	21 CFR 866.5780	2	0
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Class II	21 CFR 882.4560	38	17
PGX	Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	Class II	21 CFR 866.2680	15	4
PGY	Display, Diagnostic Radiology	Class II	21 CFR 892.2050	136	6
PGZ	Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use	Class II	21 CFR 878.4452	7	0
PHC	Infusion Safety Management Software	Class II	21 CFR 880.5725	10	13
PHF	Zinc Transporter 8 Auto-Antibody	Class II	21 CFR 866.5670	1	0
PHG	Droplet Digital Pcr System	Class II	21 CFR 862.2570	0	0
PHJ	System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations	Class II	21 CFR 864.7280	1	0
PHK	Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation	Not classified		0	0
PHL	Powered Exoskeleton	Class II	21 CFR 890.3480	26	3
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Class II	21 CFR 888.3080	3	0
PHN	Protective Coating, Mucoadhesive Application, For The Rectal Mucosa	Unclassified		5	0
PHO	Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs	Class III		0	1
PHP	System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection	Class III		0	2
PHQ	Anterior Staple As Supplemental Fixation For Fusion	Class II	21 CFR 888.3060	2	0
PHR	Diammine Silver Fluoride Dental Hypersensitivity Varnish	Class II	21 CFR 872.3260	8	0
PHS	Oral Airway Assist	Class I	21 CFR 868.5110	0	0
PHT	Basin For Endoscope Reprocessing	Class I	21 CFR 876.1500	0	0
PHU	Intra-Abdominal Pressure Monitoring Device	Unclassified		2	1
PHV	Continuous Glucose Monitor Retrospective Data Analysis Software	Class I	21 CFR 862.2120	1	2
PHW	Cold Pack And Vibrating Massager	Class I	21 CFR 890.5975	2	0
PHX	Shoulder Prosthesis, Reverse Configuration	Class II	21 CFR 888.3660	205	68
PHY	Sparse Sample Pk Profile And Dosing Software	Class II	21 CFR 868.1890	0	0
PHZ	Abnormal Breath Sound Device	Class II	21 CFR 868.1900	8	0
PIA	Vibrator For Climax Control Of Premature Ejaculation	Class II	21 CFR 876.5025	1	0
PIB	Diabetic Retinopathy Detection Device	Class II	21 CFR 886.1100	8	0
PIC	Oral Electronic Vision Aid	Class II	21 CFR 886.5905	2	1
PID	Esophageal Dilator Balloon With Or Without Electrode Sensors	Class II	21 CFR 876.5980	3	1
PIE	Esophageal Dilator With Balloon And Electrode Sensors	Class II	21 CFR 876.5980	2	0
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Class II	21 CFR 876.5980	52	112
PIG	Acute Kidney Injury Test System	Class II	21 CFR 862.1220	5	1
PIH	Urethral Insert With Pump For Bladder Drainage	Class II	21 CFR 876.5140	1	0
PII	Candida Species Nucleic Acid Detection System	Class II	21 CFR 866.3960	3	1
PIJ	Collagen Surgical Mesh Containing Drugs	Class II	21 CFR 878.3300	3	0
PIK	Metabolic Neuromodulation System	Not classified		0	0
PIL	Test For Periprosthetic Joint Infection	Not classified		0	0
PIM	Neuromodulator For Obesity	Class III		0	0
PIN	Kidney Perfusion Kit	Class II	21 CFR 876.5880	0	0
PIO	Enteral Specific Transition Connectors	Class II	21 CFR 876.5980	9	3
PIP	Prophy Powder, Airbrush Accessory	Class II	21 CFR 872.6080	2	0
PIQ	Reagents For Detection Of Norovirus Nucleic Acid	Class II	21 CFR 866.3990	1	0
PIR	Mercy Tape 2d And 3d Models	Class I	21 CFR 878.4800	2	0
PIT	Leishmania Spp. Antigen Detection Assay	Class I	21 CFR 866.3870	1	0
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Class II	21 CFR 866.4750	2	0
PIW	Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid	Class II	21 CFR 882.1450	9	0
PIX	Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis	Not classified		0	1
PIY	Stainless Steel Instrument, Shunt System Implantation	Class I	21 CFR 882.4545	0	0
PIZ	Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve	Class III		0	0
PJA	Coronary Vascular Physiologic Simulation Software	Class II	21 CFR 870.1415	9	0
PJB	Catheter Remote Control System	Class II	21 CFR 870.5700	4	1
PJC	Newborn Screening Specimen Collection Paper	Class II	21 CFR 862.1675	2	3
PJD	Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device	Class II	21 CFR 862.1675	9	0
PJE	Blood/Plasma Collection Device For Dna Testing	Class II	21 CFR 862.1675	8	0
PJF	Illuminator System For Blood Products	Class III		0	0
PJG	Cancer-Related Germline Gene Mutation Detection System	Class III		0	0
PJH	Dynamic Rectal Control System	Class II	21 CFR 876.5930	2	0
PJI	Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System	Class II	21 CFR 866.5930	2	1
PJJ	Two Or More Sterilant Sterilizer	Class II	21 CFR 880.6860	6	0
PJK	Tissue Adhesive For Internal Use	Class III	21 CFR 878.4010	0	0
PJM	Filler, Bone Void, Alterable Compound For Cranioplasty	Class II	21 CFR 882.5320	0	0
PJN	Filler, Bone Void, Non-Alterable Compound For Cranioplasty	Class II	21 CFR 882.5330	2	0
PJO	Fall Prevention Alarm/Sensor Combination Attached Or Unattached	Class I	21 CFR 880.2400	0	0
PJP	Fall Prevention Alarm/Sensor Attached Only	Class I	21 CFR 880.2400	0	0
PJQ	Agent, Occluding, Vascular, Permanent	Class III		0	2
PJS	Stimulator, Electrical, Implanted, For Essential Tremor	Class III		0	0
PJT	Continuous Glucose Monitor Secondary Display	Class II	21 CFR 862.1350	2	0
PJY	Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees	Class III		0	0
PJZ	Camera, Ophthalmic, General-Use	Class II	21 CFR 886.1120	0	0
PKA	External Upper Esophageal Sphincter (Ues) Compression Device	Class II	21 CFR 874.5900	2	0
PKB	Autosomal Recessive Carrier Screening Gene Mutation Detection System	Class II	21 CFR 866.5940	1	0
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Class II	21 CFR 888.3660	20	3
PKD	Laceration Tray	Class I	21 CFR 878.4014	0	11
PKE	Laparoscopic Cholecystectomy Kit	Class I	21 CFR 878.4800	0	2