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 52 of 71

FDA product codes, page 52 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
OBF	Assay, Genotyping, Hepatitis C Virus	Class II	21 CFR 866.3170	0	0
OBH	Monitor, Extracellular Fluid, Lymphedema, Extremity	Class II	21 CFR 870.2770	10	1
OBI	Catheter, Pressure Monitoring, Cardiac	Class II	21 CFR 870.1200	1	1
OBJ	Catheter, Ultrasound, Intravascular	Class II	21 CFR 870.1200	80	23
OBK	Port, Protector/Cushion	Class II	21 CFR 880.5965	1	1
OBL	Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty	Class II	21 CFR 888.3027	1	0
OBM	Cement, Bone, Vertebroplasty, Pre-Formed, Modular	Class II	21 CFR 888.3027	0	0
OBN	Humidifier, Respiratory, Mask (Direct Patient Interface)	Class II	21 CFR 868.5450	1	0
OBO	Tomography, Optical Coherence	Class II	21 CFR 886.1570	67	12
OBP	Transcranial Magnetic Stimulator	Class II	21 CFR 882.5805	69	5
OBR	Mouthguard, Over-The-Counter	Unclassified		47	0
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Class II	21 CFR 888.3030	6	1
OBV	Eating Disorder Conditioning Tool	Class II	21 CFR 882.5060	1	0
OBW	11-Dehydro Thromboxane B2 Kit, Urinary	Class II	21 CFR 864.5700	1	0
OBY	Condom, Female, Animal Tissue	Class III	21 CFR 884.5330	0	0
OBZ	Alpha-1-Antitrypsin Kit, Qualitative Phenotype	Class II	21 CFR 866.5130	2	0
OCB	Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection	Class III		0	0
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Class II	21 CFR 866.3980	80	25
OCE	Cultured Epithelial Autograft	Humanitarian device exemption		0	0
OCF	Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief	Class II	21 CFR 882.5890	1	0
OCG	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented	Class III	21 CFR 888.3410	0	0
OCH	Oximeter, Infrared, Sporting, Aviation	Class II	21 CFR 870.2700	0	0
OCI	Indicator, Physical/Chemical, Storage Temperature	Class II	21 CFR 880.2800	1	0
OCJ	Spinal Channeling Instrument, Vertebroplasty	Class I	21 CFR 888.4540	1	2
OCK	Transurethral Occlusion Insert, Urinary Incontinence-Control, Female	Class III		0	8
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	Class II	21 CFR 878.4400	54	17
OCM	Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation	Class III		0	0
OCN	Insulin Autoantibody Kit	Class II	21 CFR 866.5660	1	0
OCO	Mouthguard, Migraine/Tension Headache	Unclassified		3	0
OCQ	Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence	Class II	21 CFR 884.1720	0	0
OCR	Lung Sound Monitor	Class II	21 CFR 870.1875	3	0
OCS	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Class II	21 CFR 876.1500	1	1
OCT	Anti Fog Solution And Accessories, Endoscopy	Class II	21 CFR 876.1500	27	2
OCU	Endoscopic Storage Cover	Class II	21 CFR 876.1500	6	1
OCV	Endoscope Holder	Class II	21 CFR 876.1500	10	0
OCW	Endoscopic Tissue Approximation Device	Class II	21 CFR 876.1500	70	4
OCX	Endoscopic Irrigation/Suction System	Class II	21 CFR 876.1500	93	18
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Class II	21 CFR 876.1500	43	10
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Class II	21 CFR 876.1500	74	21
ODA	Endoscopic Central Control Unit	Class II	21 CFR 876.1500	18	0
ODB	Endoscopic Contamination Prevention Sheath	Class II	21 CFR 876.1500	5	0
ODC	Endoscope Channel Accessory	Class II	21 CFR 876.1500	72	3
ODD	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula	Class II	21 CFR 876.1500	18	0
ODE	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)	Class II	21 CFR 876.1500	20	4
ODF	Mini Endoscope, Gastroenterology-Urology	Class II	21 CFR 876.1500	12	0
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Class II	21 CFR 876.1500	44	10
ODH	Implantable Bladder-Evacuation Electrical Stimulation System	Humanitarian device exemption		0	0
ODI	Administration Set Docking Station	Class II	21 CFR 880.5440	1	1
ODK	Refractive Corneal Implant	Humanitarian device exemption		0	0
ODN	Ultrafiltration-Controlled Nocturnal Dialysate Delivery System	Class II	21 CFR 876.5860	2	0
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	21 CFR 888.3080	354	11
ODR	Electrosurgical Patient Return Electrode	Class II	21 CFR 878.4400	3	0
ODS	Wound Covering (Composite Cultured Skin)	Humanitarian device exemption		0	0
ODT	Tissue Adhesive, Aortic Aneurysmorrhaphy	Humanitarian device exemption		0	0
ODU	Facial Implant	Class II	21 CFR 878.3500	1	0
ODV	Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System	Class II	21 CFR 864.7750	1	0
ODW	Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System	Class II	21 CFR 862.3360	6	1
ODX	Autonomous Extracorporeal Blood Leak Detector/Alarm	Class II	21 CFR 876.5820	4	1
ODY	Tunneled Catheter Remover	Class II	21 CFR 880.5970	2	1
OEA	Non-Surgical Gown	Class I	21 CFR 878.4040	0	18
OEB	Lung Computed Tomography System, Computer-Aided Detection	Class II	21 CFR 892.2050	20	0
OED	Antimicrobial Blood Pressure Cuff	Class II	21 CFR 870.1120	2	0
OEE	Diagnostic Low Electric Field	Class III		0	0
OEG	Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230	Class II	21 CFR 866.5660	3	0
OEH	Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit	Class II	21 CFR 866.3280	2	0
OEI	Drainage Catheter With Antibiotic	Class II	21 CFR 878.4780	1	2
OEJ	Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia	Class II	21 CFR 876.4300	0	0
OEK	Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia	Class II	21 CFR 876.4300	0	0
OEL	Laser, Benign Prostatic Hyperplasia	Class II	21 CFR 878.4810	0	0
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Class II	21 CFR 866.3980	6	0
OEO	Automated Digital Image Manual Interpretation Microscope	Class II	21 CFR 864.1860	6	0
OEP	Influenza A Virus Subtype Differentiation Nucleic Acid Assay	Class II	21 CFR 866.3980	1	0
OEQ	Angiography/Angioplasty Kit	Class II	21 CFR 870.1650	0	89
OER	Angioscopic Valvulotome Kit	Class II	21 CFR 870.1650	0	0
OES	Cardiac Catheterization Kit	Class II	21 CFR 870.1200	0	93
OET	Cardioplegia Solution Administration Kit	Class II	21 CFR 870.4240	0	0
OEU	Cardiopulmonary Bypass Catheter Kit	Class II	21 CFR 870.4210	0	3
OEV	Cardiopulmonary Resuscitation Aid Kit	Class II	21 CFR 868.5915	0	36
OEW	Tracking, Soft Tissue, Intraoperative	Class II	21 CFR 882.4560	4	1
OEX	Cardiovascular Catheter Sheath Introducer Kit	Class II	21 CFR 870.1340	0	2
OEZ	Cardiovascular Procedure Kit	Class II	21 CFR 870.1200	0	226
OFA	Cardiovascular Surgical Instruments Tray	Class I	21 CFR 870.4500	0	21
OFB	Catheter Guide Wire Kit	Class II	21 CFR 870.1330	0	2
OFC	Catheter Introducer Kit	Class II	21 CFR 870.1340	1	4
OFD	Catheter Introducer Kit	Class II	21 CFR 870.1340	0	7
OFE	Central Venous Blood Pressure Kit	Class II	21 CFR 870.1140	0	0
OFF	Central Venous Catheter Tray	Class II	21 CFR 870.1140	0	50
OFG	Ct Biopsy Tray	Class II	21 CFR 870.4075	0	25
OFH	Digital Angiography Tray	Class II	21 CFR 870.1650	0	0
OFI	Laser Blood Flow Kit	Class II	21 CFR 870.2120	0	0
OFJ	Lead Introducer Kit	Class II	21 CFR 870.1340	0	0
OFK	Percutaneous Atrial Catheter Kit	Class II	21 CFR 870.1250	0	2
OFL	Percutaneous Sheath Introducer Kit	Class II	21 CFR 870.1340	0	5
OFM	Phlebotomy Blood Collection Kit	Class II	21 CFR 870.2750	0	3
OFN	Winged Intravenous Catheterization Kit	Class II	21 CFR 870.1200	0	0
OFO	Airway Suction Kit	Class I	21 CFR 868.6810	0	0
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Class I	21 CFR 868.5240	0	33
OFQ	Anesthesia Kit	Class II	21 CFR 868.5120	0	8
OFR	Tracheobronchial Suction Catheter Kit	Class I	21 CFR 868.6810	0	7
OFS	Tracheal Suction Set	Class I	21 CFR 868.6810	0	0