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 55 of 71

FDA product codes, page 55 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
OPX	Immunoglobulin A Kappa Heavy & Light Chain Combined	Class II	21 CFR 866.5510	3	0
OPY	Igal Heavy & Light Chain Combined	Class II	21 CFR 866.5510	0	0
OQB	Intervertebral Body Graft Containment Device	Class II	21 CFR 888.3085	4	0
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Class II	21 CFR 888.3358	20	2
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Class II	21 CFR 888.3350	0	0
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Class II	21 CFR 888.3353	5	4
OQL	Mesh, Surgical, Deployment Balloon	Class II	21 CFR 878.3300	1	0
OQO	Herpes Simplex Virus Nucleic Acid Amplification Assay	Class II	21 CFR 866.3305	12	1
OQQ	Diagnostic Ultrasonic Transducer, Robotic	Class II	21 CFR 892.1570	1	0
OQS	Laboratory Developed Test	Not classified		0	0
OQT	Prostate Lesion, Documentation, System	Class II	21 CFR 876.2050	1	0
OQU	Airway Monitoring System	Class II	21 CFR 868.5730	3	6
OQW	2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification	Class II	21 CFR 866.3332	10	0
OQX	Self-Contained Blood Grouping	Class II	21 CFR 864.9175	0	1
OQY	Intrauterine Tamponade Balloon	Class II	21 CFR 884.4530	11	2
OQZ	Anti-Mutated Citrullinated Vimentin Igg	Class II	21 CFR 866.5775	1	0
ORA	Breast Milk-Alcohol Test System	Class II	21 CFR 862.3040	0	1
ORC	Air Filter Portable Apparatus	Class II	21 CFR 878.5070	6	0
ORD	Optical Coherence Tomography, Intravascular Catheter	Class II	21 CFR 870.1200	0	0
ORG	Platelet And Plasma Separator For Bone Graft Handling	Class II	21 CFR 864.9245	0	0
ORH	Lamotrigine Assay	Class II	21 CFR 862.3350	2	0
ORI	Levetiracetam Assay	Class II	21 CFR 862.3350	2	0
ORK	Laser Assisted Lipolysis	Class II	21 CFR 878.4810	1	0
ORL	Whole Blood Pre-Treatment T-Cell Enrichment Reagent	Class III		0	0
ORQ	Mesh, Surgical, Deployer	Class II	21 CFR 878.3300	6	0
ORR	Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri	Class II	21 CFR 882.4560	4	0
ORT	Burst Suppression Detection Software For Electroencephalograph	Class II	21 CFR 882.1400	1	0
ORW	N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies	Class II	21 CFR 880.6260	1	0
ORY	Tongue Suspension System	Class II	21 CFR 872.5570	10	0
ORZ	Eyelid Thermal Pulsation System	Class II	21 CFR 886.5200	13	3
OSD	Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature	Class II	21 CFR 890.5670	2	0
OSE	Patient Specific Manual Navigation System	Class II	21 CFR 882.4560	0	0
OSF	Patient Specific Manual Orthopedic Stereotaxic System	Class II	21 CFR 882.4560	3	1
OSG	Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch	Class II	21 CFR 882.5894	2	0
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class II	21 CFR 888.3070	19	1
OSI	Bariatric Bed	Class II	21 CFR 880.5100	0	4
OSK	Anti-Glutamate Receptor (Type Nmda) Ifa	Class II	21 CFR 866.5660	1	0
OSL	Control, Fecal Occult Blood	Class II	21 CFR 864.6550	1	0
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Class II	21 CFR 874.3305	1	0
OSN	Software For Diagnosis/Treatment	Class II	21 CFR 888.3030	4	2
OSP	Uterine Electromyographic Monitor	Class II	21 CFR 884.2720	10	3
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Class III		0	15
OSU	Dengue Serological Reagents	Class II	21 CFR 866.3945	1	0
OSV	Insufflator, Endoscopic Vessel Harvesting	Class II	21 CFR 884.1730	0	0
OSX	Galectin-3 In Vitro Diagnostic Assay	Class II	21 CFR 862.1117	2	0
OSZ	Antimicrobial Keyboard	Class II	21 CFR 880.6600	1	0
OTA	Mass Spectrometer For Clinical Multiplex Test Systems	Class II	21 CFR 862.2570	0	1
OTD	Endovascular Suturing System	Class II	21 CFR 870.3460	7	1
OTE	Digital Breast Tomosynthesis	Class III		0	5
OTF	Gabapentin Assay	Class II	21 CFR 862.3350	1	0
OTG	Non-Sars Coronavirus Multiplex Nucleic Acid Assay	Class II	21 CFR 866.3980	0	0
OTJ	Laparoscopic Single Port Access Device	Class II	21 CFR 876.1500	11	0
OTK	Wound Drain Catheter System	Class II	21 CFR 878.4780	7	0
OTL	Femtosecond Laser System For Refractive Correction	Class III		0	1
OTM	Mesh, Surgical, For Stress Urinary Incontinence, Male	Class II	21 CFR 878.3300	12	1
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	Class II	21 CFR 878.3300	65	1
OTO	Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	Class II	21 CFR 878.3300	23	1
OTP	Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed	Class III	21 CFR 884.5980	31	0
OTQ	Research Use Only/Hematology Devices	Not classified		0	0
OTR	Research Use Only/Immunology Devices	Not classified		0	1
OTT	Research Use Only/Microbiology	Not classified		0	1
OTU	Research Use Only/Pathology	Not classified		0	1
OTV	Research Use Only/Clinical Chemistry Devices	Not classified		0	0
OTW	Research Use Only/Clinical Toxicology	Not classified		0	0
OTX	Foot Wrap For Treating Restless Leg Syndrome Symptoms	Class I	21 CFR 890.5760	1	0
OTZ	Graft Insertion Instrument For Endothelial Keratoplasty	Class I	21 CFR 886.4300	5	0
OUB	Instrument For Treatment Of Hyperhidrosis	Class II	21 CFR 878.4400	3	2
OUC	Norovirus Serological Reagent	Class II	21 CFR 866.3395	1	0
OUE	Micro Total Analysis Instrument System	Class II	21 CFR 862.2570	0	2
OUF	Everolimus Immunoassay	Class II	21 CFR 862.3840	2	1
OUG	Medical Device Data System	Class I	21 CFR 880.6310	1	24
OUH	Skin Resurfacing Rf Applicator	Class II	21 CFR 878.4400	5	1
OUJ	High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist	Class II	21 CFR 892.1570	4	1
OUK	Surgical Mask With Antimicrobial/Antiviral Agent	Class II	21 CFR 878.4040	4	0
OUL	Thermocycler, Generic	Class I	21 CFR 862.2310	0	0
OUM	Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation	Class I	21 CFR 886.1050	1	0
OUO	Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	Class II	21 CFR 892.1200	15	9
OUP	Powered Surgical Instrument For Improvement In The Appearance Of Cellulite	Class II	21 CFR 878.4790	9	1
OUR	Sacroiliac Joint Fixation	Class II	21 CFR 888.3040	132	1
OUS	Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt	Class I	21 CFR 866.2050	2	0
OUT	Intracranial Aneurysm Flow Diverter	Class III		0	14
OUU	Polymeric Neurovascular Embolization	Humanitarian device exemption		0	0
OUW	Infant Positioner, Rx, Use In Highly Monitored Setting	Class I	21 CFR 880.5680	1	2
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Class II	21 CFR 866.3860	10	4
OUZ	Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids	Class I	21 CFR 866.3870	1	0
OVA	Complete Gene Expression Profiling Accessory Reagents	Class II	21 CFR 862.2570	1	0
OVB	Hydrogel Spacer	Class II	21 CFR 892.5725	8	2
OVC	Headframe	Not classified		0	0
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	21 CFR 888.3080	205	36
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	21 CFR 888.3080	167	12
OVF	Assay, Direct, Nucleic Acid Amplification, Q Fever	Class I	21 CFR 866.3500	1	0
OVG	Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)	Humanitarian device exemption		0	0
OVJ	Pulse Generator, External Pacemaker, Dual Chamber	Class II	21 CFR 870.3600	0	0
OVK	Cytokeratin Fragments 21-1 Eia Kit	Class II	21 CFR 866.6010	3	0
OVL	Hemodialyzer, High Cut-Off	Humanitarian device exemption		0	0
OVN	Suture Kit	Class II	21 CFR 878.4830	0	10
OVO	Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation	Class III		0	0
OVP	Vibratory Counter-Stimulation	Class II	21 CFR 882.5895	1	0
OVQ	Chronic Lymphocytic Leukemia Fish Probe Kit	Class II	21 CFR 866.6040	2	1
OVR	Kit, First Aid, Talking	Class I	21 CFR 878.4014	1	0