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 71 of 71

FDA product codes, page 71 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
SEM	Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring	Class II	21 CFR 882.1360	2	0
SEN	Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety	Class II	21 CFR 882.5050	1	0
SEP	Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay	Class II	21 CFR 866.2920	2	0
SEQ	Covered Stent Vascular Connector, Hemodialysis Access Circuit	Class III		0	0
SER	Immunohistochemistry Assay, Antibody, Met	Class III	21 CFR 864.1860	0	0
SES	Non-Factor Replacement Product Test System	Class II	21 CFR 864.7298	1	0
SET	Immunoassay Blood Test For Amyloid Pathology Assessment	Class II	21 CFR 866.5840	4	7
SEU	Peripheral Temporary And Retrievable Stent System	Class II	21 CFR 870.5110	1	0
SEW	Automated Endoscope Channel Cleaner	Class II	21 CFR 880.6994	2	0
SEZ	Radiological Software Device To Predict Future Breast Cancer Risk	Class II	21 CFR 892.8500	1	0
SFA	Prosthesis, Finger, Semi-Constrained, Metal/Polymer	Class III		0	0
SFC	Neurologic Disease Risk Assessment Molecular Test	Class II	21 CFR 866.5850	1	0
SFD	In Situ Polymerizing Peripheral Nerve Repair Device	Class II	21 CFR 882.5270	2	8
SFE	Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation	Class II	21 CFR 876.1500	2	0
SFG	Camera, Surgical, Measurement	Class I	21 CFR 878.4160	1	0
SFH	Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis	Class II	21 CFR 864.3755	1	0
SFI	Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System	Class III		0	0
SFJ	Vagus Nerve Stimulator For Rheumatoid Arthritis	Class III		0	0
SFK	Respiratory Effort Belt For Polysomnography	Class II	21 CFR 882.1400	1	0
SFL	Nucleic Acid Based Assay, Microsatellite Instability	Class III		0	0
SFN	Non-Invasive Evoked Response Brain Stimulator	Class II	21 CFR 882.1860	1	0
SFO	Electrode Measurement, Drain Effluent Ph	Class II	21 CFR 862.1120	1	0
SFP	Ventilator-Compatible Nebulizer	Class II	21 CFR 868.5630	2	0
SFQ	Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision	Class II	21 CFR 878.4400	0	0
SFR	Hypertension Machine Learning-Based Notification Software	Class II	21 CFR 870.2380	1	0
SFS	Revumenib Eligibility Detection System	Class II	21 CFR 864.1885	1	0
SFU	Glucose Range Monitoring System	Class II	21 CFR 862.1359	2	0
SFV	X-Ray, Computed Tomography, Cone-Beam	Class II	21 CFR 892.1750	1	0
SFW	Cranial Electrotherapy Stimulator For Weight Management	Class I	21 CFR 876.5984	1	0
SGA	Biothreat Microbial Agent Nucleic Acid Detection Test	Class II	21 CFR 866.4000	2	0
SGB	Pain Assessment Software In Non-Communicative Adults	Class II	21 CFR 882.1472	1	0
SGD	Kit D816v Mutation Detection System	Humanitarian device exemption		0	0
SGE	Extracranial Positional System For A Transcranial Magnetic Stimulation System	Class II	21 CFR 882.4560	1	0
SGF	Dural Arteriovenous Fistula Liquid Embolic	Humanitarian device exemption		0	0
SGG	Mass Spectrometric, Immunoglobulins (G, A, M, D, E)	Class II	21 CFR 866.5510	1	0
SGH	Ultrasound Imaging For Vascular Access For Hemodialysis	Class II	21 CFR 892.1560	1	0
SGJ	Ultrasound Imaging System For Acquiring Images At Home By Lay Users	Class II	21 CFR 892.1590	1	0
SGK	Prosthesis, Spinous Process Tension Band Implant	Class III		0	0
SGL	Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant	Class II	21 CFR 888.4520	1	0
SGN	High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation	Class II	21 CFR 882.4420	1	0
SGO	Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures	Class II	21 CFR 870.1254	1	0
SGQ	Intraoral Phototherapy Device	Class II	21 CFR 872.5595	1	0
SGR	Noninvasive Positive Airway Pressure System, Facility Use	Class II	21 CFR 868.5895	2	0
SGS	Deep Brain Stimulation For The Treatment Of Dystonia	Class III		0	0
SGT	Electromagnetic Stimulator For Healthy Muscle Stimulation	Class II	21 CFR 890.5850	2	0
SGU	Neurovascular Liquid Embolic Agent	Class III		0	0
SGV	Agent, Absorbable Hemostatic, Collagen With Polymeric Additives	Class III	21 CFR 878.4490	0	0
SGW	Device To Detect Antibodies To Hepatitis D Virus	Class II	21 CFR 866.3176	1	0
SGX	Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves	Class II	21 CFR 880.6512	1	0
SGY	Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant	Class II	21 CFR 876.5881	1	0
SGZ	Ultraviolet Lamp Products	Class II	21 CFR 878.4635	1	0
SHA	Solid Wound Dressing With Permanently Bound Antimicrobial Agent	Class II	21 CFR 878.4013	1	0
SHB	Creatinine Test System For At Home Prescription Use	Class II	21 CFR 862.1225	1	0
SHC	Low Electric Field Generator For Pancreatic Cancer Treatment	Class III		0	0
SHE	Radiological Software System For Delivery Date Prediction	Class II	21 CFR 892.8200	1	0
SHH	Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer	Class III		0	0
SHI	Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter	Class II	21 CFR 872.3660	3	0
SHL	Ear, Nose, And Throat Image Analyzer	Class II	21 CFR 874.4775	2	0
SHM	Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe	Class II	21 CFR 880.6891	1	0
SHN	Calibration Software For Radiology Displays	Class I	21 CFR 892.1940	1	0
SHO	Parkinsonian Syndrome Diagnostic Aid	Class II	21 CFR 882.2000	1	0
SHP	Cardiac Amyloidosis Machine Learning-Based Notification Software	Class II	21 CFR 870.2380	1	0
SHQ	Dental Image Analyzer, In-Office	Class II	21 CFR 872.1770	1	0
SHR	Device For Open Surgical Explant Of Endovascular Prostheses	Class II	21 CFR 870.4520	1	0
SHU	Appendiceal Scope And Accessories, Flexible	Class II	21 CFR 876.1500	1	0
SHV	Reusable Intermittent Urinary Catheter System	Class II	21 CFR 876.5120	1	0
SHW	Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis	Class II	21 CFR 864.3755	2	0
SHX	Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms	Class II	21 CFR 882.5807	1	0
SHY	Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.	Class II	21 CFR 878.1840	1	0
SIA	Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test	Class II	21 CFR 866.3984	1	0
SIB	Tempo Pilot Eckm: Early Cardio-Kidney-Metabolic	Not classified		0	0
SIC	Tempo Pilot Ckm: Cardio-Kidney-Metabolic	Not classified		0	0
SID	Tempo Pilot Msk: Musculoskeletal	Not classified		0	0
SIE	Tempo Pilot Bh: Behavioral Health	Not classified		0	0
SIF	Software Device System For Estimation Of Cardiac Pressures	Class II	21 CFR 870.1150	1	0
SIG	Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)	Class II	21 CFR 882.5802	1	0
SIH	Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay	Class II	21 CFR 866.2920	1	0
SII	Aortic Stenosis Machine Learning-Based Notification Software	Class II	21 CFR 870.2380	0	0
SIJ	Valvular Regurgitation Machine Learning-Based Notification Software	Class II	21 CFR 870.2380	0	0
SIK	Cardiac Hypertrophy Machine Learning-Based Notification Software	Class II	21 CFR 870.2380	0	0
SIL	Wound Dressings Containing Oxygen	Unclassified		0	0
SIM	Gynecologic Power Morcellator And Containment System	Class II	21 CFR 884.4075	1	0
SIN	Automated Intraoperative Spinal Rod Bending System	Class II	21 CFR 888.3070	1	0
SIO	Test For Esophageal Varices	Class III		0	0
SIQ	Intra-Articular Orthopedic Stereotaxic Navigation Instrument	Class II	21 CFR 888.4561	1	0
SIR	Integrated Operating Table-Electromechanical Surgical System	Class II	21 CFR 878.4966	1	0
SIT	Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System	Class II	21 CFR 888.1150	1	0
SIU	Predictive Indicator For Long-Term Cardiovascular Outcomes	Class II	21 CFR 870.2215	1	0
SIW	Robotic Peripheral Venous Blood Collection System	Class II	21 CFR 880.6975	1	0
SIX	Digital Pathology Image Artifact Detection Software Device	Class II	21 CFR 864.3700	0	0
SJA	Injectable For Thermal Treatment Of Musculoskeletal Pain	Class II	21 CFR 888.3048	1	0
SJB	Powered Fecal Management System	Class II	21 CFR 876.5230	1	0
SJD	Integrated Continuous Glucose Ketone Monitoring System	Class II	21 CFR 862.1354	1	0
SJH	Portable Dental Operative Unit	Class I	21 CFR 872.6640	1	0