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 57 of 71

FDA product codes, page 57 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
PAN	Braf Mutation Kit	Not classified		0	0
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Class II	21 CFR 888.3660	1	3
PAP	Aortic Heart Valve, More Than Minimally Manipulated Allograft	Humanitarian device exemption		0	0
PAQ	Test, Nr2 Antibody	Not classified		0	0
PAR	Test, Volatile Organic Compounds Breath Analysis	Humanitarian device exemption		0	0
PAS	Rf/Microwave Hyperthermia System, Cancer Treatment	Humanitarian device exemption		0	0
PAT	Bladder System	Humanitarian device exemption		0	0
PAV	Catheter, Neuro-Vasculature, Occluding Balloon	Humanitarian device exemption	21 CFR 882.5150	0	1
PAW	Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement	Class II	21 CFR 870.3470	3	1
PAX	Surgical Kit	Humanitarian device exemption		0	2
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	Class II	21 CFR 878.4420	12	0
PAZ	Electrical Stimulation Bladder System	Humanitarian device exemption		0	0
PBA	Ecarin Clotting Time	Humanitarian device exemption		0	0
PBC	Manual Blood Grouping And Antibody Test Systems	Class II	21 CFR 864.9175	0	0
PBD	Composite Cultured Skin	Humanitarian device exemption	21 CFR 878.4024	0	0
PBF	Orthopaedic Surgical Planning And Instrument Guides	Class II	21 CFR 888.3030	27	0
PBH	Embryo Image Assessment System, Assisted Reproduction	Class II	21 CFR 884.6195	5	0
PBI	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive	Class II	21 CFR 888.3310	2	2
PBJ	Cranial Distraction System	Class II	21 CFR 882.5330	6	0
PBK	Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set	Class II	21 CFR 866.3315	5	0
PBN	Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients	Humanitarian device exemption		0	0
PBP	Rectal Insert	Class II	21 CFR 876.5980	2	0
PBQ	Fixation, Non-Absorbable Or Absorbable, For Pelvic Use	Class II	21 CFR 884.4530	8	1
PBU	Bone Void Filler, Syringe	Not classified		0	0
PBX	Massager, Vacuum, Radio Frequency Induced Heat	Class II	21 CFR 878.4400	80	1
PBY	Temporary Tissue Marker	Class II	21 CFR 878.4300	7	0
PBZ	Image Processing Device For Estimation Of External Blood Loss	Class II	21 CFR 880.2750	6	4
PCA	Dna Genetic Analyzer	Class II	21 CFR 862.2570	1	0
PCB	External Cerebrospinal Fluid (Csf) Diversion	Class II	21 CFR 882.5560	2	5
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	Class II	21 CFR 882.5891	18	0
PCD	Powered Stairway Chair Lift	Class II	21 CFR 890.5150	0	3
PCE	Permanently Mounted Wheelchair Platform Lift	Class II	21 CFR 890.3930	1	0
PCF	Sampler, Endocervical	Class II	21 CFR 884.1050	5	0
PCG	21-Hydroxylase Antibody (21-Ohab)	Class II	21 CFR 866.5660	2	0
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Class II	21 CFR 866.3990	38	24
PCI	Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System	Class II	21 CFR 866.3990	5	0
PCK	Pediatric Ventricular Assist Device	Humanitarian device exemption	21 CFR 870.3545	0	0
PCL	Enzyme Linked Immunoabsorbent Assay, Rubeola Igm	Class I	21 CFR 866.3520	1	3
PCM	Portable Liquid Oxygen Unit Stand	Class I	21 CFR 890.5050	1	0
PCN	Immunoglobulin G Kappa Heavy And Light Chain Combined	Class II	21 CFR 866.5510	3	0
PCO	Immunoglobulin G Lambda Heavy And Light Chain Combined	Class II	21 CFR 866.5510	0	0
PCQ	Inhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)	Not classified		0	0
PCS	Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox	Class II	21 CFR 892.1001	3	0
PCT	Prostate Immobilizer Rectal Balloon	Class II	21 CFR 892.5720	5	2
PCU	Pancreatic Stent, Covered, Metallic, Removable	Class II	21 CFR 876.5015	11	6
PCV	Endoscopic Leak Tester	Class II	21 CFR 876.1500	2	0
PCW	Implantable Pulse Generator, Programmer And Battery Charger	Not classified		0	0
PCX	Artificial Chordae Tendinae Delivery System	Not classified		0	0
PCY	Investigational Use Only - Microbiology	Not classified		0	0
PCZ	Investigational Use Only - Immunology	Not classified		0	0
PDA	Investigational Use Only - Clinical Chemistry	Not classified		0	0
PDB	Investigational Use Only - Clinical Toxicology	Not classified		0	0
PDC	Investigational Use Only - Hematology	Not classified		0	0
PDD	Investigational Use Only - Pathology	Not classified		0	0
PDE	Immunoglobulin M Kappa Heavy And Light Chain Combined	Class II	21 CFR 866.5510	2	0
PDF	Immunoglobulin M Lambda Heavy And Light Chain Combined	Class II	21 CFR 866.5510	0	0
PDG	Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.	Class II	21 CFR 878.4400	1	0
PDH	Blanket, Neonatal Phototherapy	Class II	21 CFR 880.5700	2	1
PDI	Beta 2-Microglobulin Apheresis Column	Humanitarian device exemption		0	0
PDJ	Hemoglobin A1c Test System	Class II	21 CFR 862.1373	26	9
PDK	Cream For X-Ray Attenuation	Class II	21 CFR 892.6510	2	0
PDO	Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization	Class II	21 CFR 864.1870	1	0
PDQ	Neurosurgical Nerve Locator	Class II	21 CFR 874.1820	36	2
PDR	Computer-Assisted Personalized Sedation System	Class III		0	1
PDS	Amniotic Fluid Protein Immunoassay	Class I	21 CFR 862.1550	0	0
PDT	Burn Resuscitation Decision Support Software	Class II	21 CFR 868.1890	2	1
PDU	Catheter For Crossing Total Occlusions	Class II	21 CFR 870.1250	58	7
PDW	Internal Tissue Marker	Class II	21 CFR 878.4670	3	0
PDX	Flow Cytometry Calibrator	Class II	21 CFR 864.5220	0	0
PDY	Organophosphate Test System	Class II	21 CFR 862.3652	1	0
PDZ	Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis	Class II	21 CFR 878.4810	19	1
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Class II	21 CFR 876.1500	9	4
PEB	Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible	Class II	21 CFR 884.5300	10	0
PEC	Sterilizer Automated Loading System	Class II	21 CFR 880.6880	1	0
PEF	Heparin Flush In 0.45% Sodium Chloride	Class II	21 CFR 880.5200	0	0
PEG	Nucleic Acid Quantitation Kit	Class I	21 CFR 862.2310	0	0
PEH	Hemodialysis Catheter Luer End Cap	Class II	21 CFR 876.5540	2	1
PEJ	Salivary Estriol Test	Class III		0	1
PEK	Spinous Process Plate	Class II	21 CFR 888.3050	48	1
PEM	Dental Barriers And Sleeves	Class II	21 CFR 878.4370	17	0
PEN	Gram-Negative Bacteria And Associated Resistance Markers	Class II	21 CFR 866.3365	12	20
PEO	Fungal Organisms, Nucleic Acid-Based Assay	Class II	21 CFR 866.3365	2	0
PEP	Molecular Erythrocyte Typing Test	Class III		0	1
PEQ	Accessories To Examination Light	Class I	21 CFR 880.6320	1	0
PER	Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis	Class I	21 CFR 862.2750	3	10
PET	Anti-Ss-A Ro60 Autoantibodies	Class II	21 CFR 866.5100	0	0
PEU	System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen	Class II	21 CFR 866.3373	2	1
PEV	Dialysis Administration Kit	Class II	21 CFR 876.5820	0	6
PEW	Implantable Transprostatic Tissue Retractor System	Class II	21 CFR 876.5530	11	2
PEX	System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Class II	21 CFR 866.3361	5	3
PEZ	Central Venous Catheter Dressing Change Kit	Class II	21 CFR 880.5200	0	4
PFA	Non-Invasive Central Venous Manometer	Class II	21 CFR 870.1140	2	0
PFC	Cultured Human Cell Skin Dressing	Class III		0	0
PFE	Gastrointestinal Liner System	Not classified		0	0
PFF	High Throughput Dna Sequence Analyzer	Class II	21 CFR 862.2265	2	11
PFG	Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders	Class II	21 CFR 864.1870	1	0
PFH	Venous Window Needle Guide	Class II	21 CFR 876.5540	1	0
PFJ	Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor	Class II	21 CFR 884.4260	2	1
PFK	Quality Control For Molecular Immunohematology Tests	Class II	21 CFR 864.9650	0	0
PFL	Intraoral, Dental Foam Protector	Class I	21 CFR 872.6890	1	0