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 54 of 71

FDA product codes, page 54 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
OKF	Body Fluid Disposal Kit	Class II	21 CFR 878.4040	0	0
OKG	Body Fluid Clean Up Kit	Class II	21 CFR 878.4040	0	3
OKH	Body Fluids Barrier Kit	Class II	21 CFR 878.4040	0	0
OKI	Emergency Response Safety Kit	Class II	21 CFR 878.4040	0	5
OKJ	Light Based Treatment For Cold Sores Herpes Simplex Virus-1	Class II	21 CFR 878.4860	4	0
OKL	Intravascular Administration Set, Automated Air Removal System	Class II	21 CFR 880.5445	2	0
OKM	Antibodies, Outer-Membrane Proteins	Class II	21 CFR 866.5785	1	0
OKN	Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy	Class III		0	0
OKO	Negative Pressure Wound Therapy Non-Powered Suction Apparatus	Class II	21 CFR 878.4683	18	0
OKP	Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache	Class II	21 CFR 882.5808	6	0
OKR	Ventricular Bypass (Assist) Device	Class III	21 CFR 870.3545	0	0
OKS	Lacrimal Stents And Intubation Sets	Unclassified		31	0
OKU	Emergency Obstetrical Kit	Class I	21 CFR 884.4520	0	0
OKV	Obstetrical Kit	Class II	21 CFR 884.4520	0	91
OKW	Seminal Fluid Collection Kit	Class II	21 CFR 884.5300	0	0
OKX	Trocar Kit	Class II	21 CFR 884.1720	0	0
OKY	Cytology Kit	Class II	21 CFR 884.4530	0	0
OKZ	Endometrial Sampling Kit	Class II	21 CFR 884.1175	0	0
OLC	Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen	Class II	21 CFR 878.3300	3	1
OLD	Internal Polymerase Chain Reaction Control, Not Assay Specific	Class I	21 CFR 862.1660	1	0
OLF	Medevac Use Oxygen Generator	Class II	21 CFR 868.5440	1	0
OLH	Orchidometer	Class I	21 CFR 876.4730	0	0
OLI	Fat Reducing Low Level Laser	Class II	21 CFR 878.5400	33	3
OLK	Pulse Oximeter For Over-The-Counter Use	Class II	21 CFR 870.2700	2	0
OLL	Septal Stapler/Absorbable Staples	Class II	21 CFR 878.4750	1	0
OLM	Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)	Humanitarian device exemption		0	0
OLO	Orthopedic Stereotaxic Instrument	Class II	21 CFR 882.4560	440	113
OLP	Over-The-Counter Powered Light Based Laser For Acne	Class II	21 CFR 878.4810	51	4
OLQ	Cross-Sectional Mammographic Xray System	Class III		0	0
OLR	Oral Wound Dressing	Unclassified		43	1
OLS	Oral Wound Dressing W/Drug And/Or Biologic	Unclassified		0	0
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Class II	21 CFR 882.1400	57	0
OLU	Normalizing Quantitative Electroencephalograph Software	Class II	21 CFR 882.1400	13	0
OLV	Standard Polysomnograph With Electroencephalograph	Class II	21 CFR 882.1400	65	1
OLW	Index-Generating Electroencephalograph Software	Class II	21 CFR 882.1400	40	1
OLX	Source Localization Software For Electroencephalograph Or Magnetoencephalograph	Class II	21 CFR 882.1400	25	0
OLY	Magnetoencephalograph	Class II	21 CFR 882.1400	6	0
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Class II	21 CFR 882.1400	37	0
OMA	Amplitude-Integrated Electroencephalograph	Class II	21 CFR 882.1400	16	3
OMB	Automatic Event Detection Software For Full-Montage Electroencephalograph	Class II	21 CFR 882.1400	42	1
OMC	Reduced- Montage Standard Electroencephalograph	Class II	21 CFR 882.1400	29	0
OMD	Cutaneous Tissue Adhesive With Mesh	Class II	21 CFR 878.4011	9	0
OME	Extracorporeal Shock Wave Treatment	Class III		0	0
OMF	Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position	Class II	21 CFR 880.5970	2	0
OMG	Antisera, Fluorescent, Human Metapneumovirus	Class II	21 CFR 866.3980	4	0
OMH	Pericardial Patch To Facilitate Revision Surgeries	Class II	21 CFR 870.3470	1	0
OMI	Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv	Class II	21 CFR 866.3510	2	1
OMJ	Chest X-Ray Computer Aided Detection	Class II	21 CFR 892.2050	1	0
OMM	Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr	Class II	21 CFR 864.7280	2	0
OMN	C. Difficile Nucleic Acid Amplification Test Assay	Class I	21 CFR 866.2660	5	2
OMP	Negative Pressure Wound Therapy Powered Suction Pump	Class II	21 CFR 878.4780	215	47
OMR	Vessel Guard Or Cover	Class II	21 CFR 870.3470	10	0
OMS	Novel Influenza A Virus, A/H5 Ns1 Protein	Class II	21 CFR 866.3332	1	0
OMT	Absorbable Lung Biopsy Plug	Class II	21 CFR 878.4755	2	1
OMV	Ultrasonic Body Composition Analyzer	Class II	21 CFR 870.2770	1	0
OMW	Adhesive Backed Thermal Skin Patches	Class I	21 CFR 890.5710	0	0
OMX	High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis	Humanitarian device exemption		0	0
OMZ	Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter	Class II	21 CFR 870.1250	5	0
ONA	Computer Assisted Hair Harvesting System	Class II	21 CFR 882.4560	4	4
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	Class II	21 CFR 880.5440	41	73
OND	Osmolality Of Tears	Class I	21 CFR 862.1540	1	0
ONE	Powered Light Based Non-Laser Surgical Instrument	Class II	21 CFR 878.4810	7	0
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	Class II	21 CFR 878.4810	74	0
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	Class II	21 CFR 878.4810	35	4
ONJ	Dissolvable Gel For Preventing Ureteral Stone Migration	Class II	21 CFR 876.4680	1	0
ONK	Oral Lubricant	Class I	21 CFR 880.6375	1	0
ONL	Conformal Brachytherapy Source	Class II	21 CFR 892.5730	1	0
ONM	Radiant Infant Warmer Cabinet	Class II	21 CFR 880.5130	0	0
ONN	Intraoperative Orthopedic Joint Assessment Aid	Class II	21 CFR 882.4560	18	8
ONO	Neurosurgical Laser With Mr Thermography	Class II	21 CFR 878.4810	8	1
ONQ	Electrosurgical Coagulation For Aesthetic	Class II	21 CFR 878.4400	4	0
ONT	N95 Respirator With Antimicrobial/Antiviral Agent	Class II	21 CFR 878.4040	6	0
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Class III		0	1
ONV	Electrical Impedance Spectrometer	Class II	21 CFR 878.1820	0	0
ONW	Hemodialysis System For Home Use	Class II	21 CFR 876.5860	4	4
ONX	Ovarian Adnexal Mass Assessment Score Test System	Class II	21 CFR 866.6050	6	0
ONY	Oral Removable Retainer For Weight Management	Class II	21 CFR 876.5981	2	0
ONZ	Mechanical Ventilator	Class II	21 CFR 868.5895	6	0
OOA	Hemorrhoid Prevention Pressure Wedge	Class II	21 CFR 884.5200	1	0
OOB	Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter	Class III		0	0
OOD	Surgical Film	Class II	21 CFR 878.3300	13	1
OOE	Ophthalmic Femtosecond Laser	Class II	21 CFR 886.4390	47	8
OOF	Cryogenic Cord Blood Storage Container	Class II	21 CFR 864.9900	0	0
OOG	Knee Arthroplasty Implantation System	Class II	21 CFR 888.3560	2	3
OOI	Real Time Nucleic Acid Amplification System	Class II	21 CFR 862.2570	14	30
OOK	Dermal Cooling Pack/Vacuum/Massager	Class II	21 CFR 878.4340	14	6
OOL	Electronic Depth Gauge	Class II	21 CFR 888.3030	1	0
OOU	Parainfluenza Multiplex Nucleic Acid Assay	Class II	21 CFR 866.3980	5	0
OOW	Applicator For Rectal Suppository	Class I	21 CFR 876.4730	1	0
OOX	Automated Occult Blood Analyzer	Class II	21 CFR 864.6550	6	0
OOY	Bronchial Thermoplasty System	Class III		0	1
OPC	Powder-Free Polychloroprene Patient Examination Glove	Class I	21 CFR 880.6250	1	0
OPH	Radiation Attenuating Medical Glove	Class I	21 CFR 880.6250	0	0
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	Class I	21 CFR 880.6250	0	0
OPL	Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus	Class II	21 CFR 866.3510	3	1
OPM	Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2	Class II	21 CFR 866.3510	1	0
OPN	Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex	Class II	21 CFR 866.5660	1	0
OPP	Pump, Infusion, Insulin Bolus	Class II	21 CFR 880.5725	7	1
OPR	Intrasaccular Flow Disruption Device	Class III		0	1
OPT	Infrared Hematoma Detector	Class II	21 CFR 882.1935	5	1