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 53 of 71

FDA product codes, page 53 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
OFT	Spinal Epidural Anesthesia Kit	Class II	21 CFR 868.5120	0	40
OFU	Spinal Anesthesia Kit	Class II	21 CFR 868.5120	0	3
OFV	Regional Anesthesia Kit	Class II	21 CFR 868.5120	0	0
OFW	Restorative Instrument And Component Tray	Class II	21 CFR 872.3690	0	0
OFX	General Purpose Dental Tray	Class I	21 CFR 872.6640	0	21
OFY	Dental Implant Surgical Tray	Class I	21 CFR 872.3980	0	1
OFZ	Blood Specimen Collection Kit (Excludes Hiv Testing)	Class I	21 CFR 868.1100	0	1
OGA	Brachial Plexus Anesthesia Kit	Class II	21 CFR 868.5140	0	0
OGB	Caudal Anesthesia Kit	Class II	21 CFR 868.5140	0	0
OGC	Continuous Brachial Plexus Block Tray	Class II	21 CFR 868.5150	0	0
OGD	Custom Anesthesia Tray	Class II	21 CFR 868.5120	0	7
OGE	Epidural Anesthesia Kit	Class II	21 CFR 868.5120	0	33
OGF	Glossopharyngeal Anesthesia Kit	Class II	21 CFR 868.5120	0	0
OGG	Humidifier Nebulizer Kit	Class II	21 CFR 868.5450	0	2
OGH	Laryngoscope Kit	Class I	21 CFR 868.5540	0	4
OGI	Nasal Endotracheal Tube Holder Kit	Class I	21 CFR 868.5770	0	1
OGJ	Nerve Block Tray	Class II	21 CFR 868.5140	0	46
OGK	Orotracheal Intubation Guide Kit	Class II	21 CFR 868.1400	0	2
OGL	Oxygen Administration Kit	Class II	21 CFR 868.5655	0	1
OGO	Intraocular Pressure Lowering Implant	Class III		0	4
OGP	Cricothyrotomy Kit	Class II	21 CFR 868.5800	0	0
OGQ	Ear Irrigation Kit	Class I	21 CFR 880.6960	0	0
OGR	Ear, Nose, And Throat Surgical Tray	Class I	21 CFR 874.4420	0	76
OGS	Myringotomy Procedure Kit	Class II	21 CFR 874.3880	0	1
OGT	Oral Irrigation Kit	Class I	21 CFR 872.6510	0	0
OGU	Pierced Ear/Entry Cleaning Tray	Class I	21 CFR 874.4420	0	0
OGV	Tracheostomy Cleaning Tray	Class II	21 CFR 868.5800	0	1
OGW	Tracheostomy Kit	Class II	21 CFR 868.5800	0	0
OGZ	Catheter, Intravascular, Plaque Morphology Evaluation	Class II	21 CFR 870.1200	9	1
OHA	Heart Valve, More Than Minimally Manipulated Allograft	Unclassified		4	4
OHC	Obstetrical Vacuum Delivery Kit	Class II	21 CFR 884.4340	0	0
OHD	Gynecological Laparoscopic Kit	Class II	21 CFR 884.1720	0	55
OHE	Forensic Evidence Sexual Assault Kit	Class II	21 CFR 884.1630	0	0
OHF	Culdocentesis Kit	Class II	21 CFR 884.1640	0	0
OHG	Circumcision Tray	Class II	21 CFR 884.4530	0	20
OHH	Breast Pump Kit	Class II	21 CFR 884.5160	0	1
OHI	Orthosis, Foot Drop	Class I	21 CFR 890.3475	1	0
OHL	Pap Smear Kit	Class II	21 CFR 884.4530	0	0
OHM	Cesarean Section Tray	Class II	21 CFR 884.1720	0	74
OHO	First Aid Kit Without Drug	Class I	21 CFR 878.4014	0	1
OHP	Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea	Class II	21 CFR 872.5570	5	2
OHQ	Multi-Analyte Controls Unassayed	Class I	21 CFR 862.1660	0	24
OHR	Catheter Care Tray	Class II	21 CFR 876.5130	0	16
OHS	Light Based Over The Counter Wrinkle Reduction	Class II	21 CFR 878.4810	163	4
OHT	Light Based Over-The-Counter Hair Removal	Class II	21 CFR 878.4810	165	0
OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	Class II	21 CFR 878.4590	30	1
OHW	Burr, Corneal, Battery Powered, Rust Ring Removal	Class I	21 CFR 886.4070	0	1
OHX	Burr, Corneal, Ac-Powered, Rust Ring Removal	Class I	21 CFR 886.4070	0	0
OHY	Pill Crusher/Cutter	Class I	21 CFR 880.6430	0	1
OHZ	Urine Transport Kit (Excludes Hiv Testing)	Class I	21 CFR 864.3250	0	0
OIA	Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)	Class I	21 CFR 864.3250	0	0
OIB	Blood And Urine Collection Kit (Excludes Hiv Testing)	Class I	21 CFR 864.3250	0	29
OIC	Blood Alcohol Kit (Excludes Hiv Testing)	Class II	21 CFR 862.3040	0	0
OID	Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing)	Class I	21 CFR 866.2900	0	0
OIE	Urine Collection Kit (Excludes Hiv Testing)	Class I	21 CFR 864.3250	0	1
OIF	Tyrosine Phosphatase (Ia-2) Autoantibody Assay	Class II	21 CFR 866.5660	3	0
OIG	Powder-Free Guayle Rubber Examination Glove	Class I	21 CFR 880.6250	1	2
OIH	Yersinia Spp. Reagents	Unclassified		1	0
OII	Arthrogram Tray	Class II	21 CFR 892.1650	0	9
OIJ	Biopsy Needle Guide Kit	Class II	21 CFR 892.1560	0	2
OIK	Radiology Dental Tray	Class II	21 CFR 892.1650	0	0
OIL	Discography Kit	Class II	21 CFR 892.1730	0	0
OIM	Mri Disposable Kit	Class II	21 CFR 892.1000	0	0
OIN	Prostate Seeding Kit	Class II	21 CFR 892.5730	0	0
OIO	Radiographic Contrast Tray	Class II	21 CFR 892.1680	0	0
OIP	Radiology-Diagnostic Kit	Class II	21 CFR 892.1680	0	5
OIR	Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator	Class III		0	2
OIS	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	Class II	21 CFR 888.3045	1	1
OIU	Test, Epithelial Ovarian Tumor Associated Antigen (He4)	Class II	21 CFR 866.6010	5	0
OIV	Dental Amalgam	Class II	21 CFR 872.3070	3	0
OIW	Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types	Class II	21 CFR 862.3100	4	0
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Class II	21 CFR 888.3560	12	6
OIZ	Foot Examination Tool For Inflammatory Changes	Class I	21 CFR 890.5050	2	0
OJA	Intravenous Extension Tubing Set	Class II	21 CFR 880.5440	1	4
OJB	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate	Class II	21 CFR 888.3060	3	0
OJE	Right Ventricular Bypass (Assist) Device	Humanitarian device exemption		0	0
OJF	Hysterectomy Kit	Class II	21 CFR 884.4530	0	29
OJG	Neurological Tray	Class I	21 CFR 882.4525	0	92
OJH	Orthopedic Tray	Class I	21 CFR 878.4800	0	238
OJI	Burn Kit With Drug	Not classified		0	0
OJJ	Burn Kit Without Drug	Class I	21 CFR 878.4022	0	7
OJK	Eye Tray	Class II	21 CFR 886.4790	0	73
OJL	Insulin Vial Protector/Holder	Class I	21 CFR 890.5050	0	0
OJM	Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh	Class II	21 CFR 888.3060	0	0
OJN	Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test	Class III		0	5
OJO	Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria	Not classified		0	0
OJP	Orthopedic Computer Controlled Surgical System	Class II	21 CFR 882.4560	4	0
OJQ	Cardiac Allograft Gene Expression Profiling Test System	Class II	21 CFR 862.1163	2	0
OJR	Vacuum Powered Body Fluid Collection Kit	Class II	21 CFR 878.4780	0	1
OJS	Tourniquet Kit	Class I	21 CFR 878.5900	0	0
OJT	Aspiration Tray	Class I	21 CFR 878.4800	0	0
OJU	Skin Prep Tray	Class I	21 CFR 878.4800	1	21
OJV	Single Use Instrument Tray	Class I	21 CFR 878.4800	0	38
OJW	Shave Prep Kit	Class II	21 CFR 878.4370	0	0
OJX	Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	Class III		0	0
OJY	Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers	Class II	21 CFR 866.3236	1	0
OJZ	Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde	Humanitarian device exemption		0	1
OKC	Implanted Subcutaneous Securement Catheter	Class II	21 CFR 880.5970	5	1
OKD	Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone Nonunion	Humanitarian device exemption		0	0
OKE	Port Introducer Kit	Class II	21 CFR 880.5965	0	10