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 70 of 71

FDA product codes, page 70 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
RIF	Smart Meter	Not classified		0	0
RIG	Laser Illuminated Projector	Not classified		0	0
RIH	Metal Halide Lamp, Other	Not classified		0	0
RII	Scientific Optical Instrument, Noncoherent	Not classified		0	0
RIJ	Automotive Radar	Not classified		0	0
RIK	Television Or Monitor, Non-Crt, Non-Medical, Video Display	Not classified		0	0
RIL	Laser Ignition Tool	Not classified		0	0
RIM	Laser Marker, Cutter, Or Engraver, Tabletop, Consumer	Not classified		0	1
RIN	Laser Illuminated Lighting Instrument	Not classified		0	0
RIO	Led Toys And Entertainment Products	Not classified		0	0
RIP	Led Diodes Sold As Components To Be Installed In Finished Electronic Products	Not classified		0	0
RIQ	Low Emission Leds As Indicators Or Decorations	Not classified		0	0
SAB	Table Mounted Miniaturized Electromechanical Surgical System	Class II	21 CFR 878.4962	2	1
SAC	Adamts13 Activity Test System	Class II	21 CFR 864.7297	1	0
SAD	Japanese Encephalitis Virus Immunological/Serology Test	Not classified		0	0
SAF	Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter	Class II	21 CFR 862.1355	4	0
SAH	Magnetic Compression Anastomosis System	Class II	21 CFR 878.4816	9	0
SAI	Ankle Fusion Cage	Class II	21 CFR 888.3020	2	0
SAK	Software Device To Aid In The Prediction Or Diagnosis Of Sepsis	Class II	21 CFR 880.6316	2	0
SAL	Device, Automated Cell Locating, Bone Marrow	Class II	21 CFR 864.5261	1	0
SAM	Battery-Powered Instruments Charged Through Sterile Barriers	Class I	21 CFR 878.4820	1	0
SAN	Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples	Class II	21 CFR 866.1650	8	0
SAO	Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density	Class II	21 CFR 892.1171	3	0
SAP	Computerized Behavioral Therapy Device For Depressive Disorders.	Class II	21 CFR 882.5801	3	0
SAQ	Electromechanical System For Open Microsurgery	Class II	21 CFR 878.4963	5	0
SAR	Adjunctive Hemodynamic Indicator With Decision Point For Military Use	Class II	21 CFR 870.2220	1	0
SAT	Pulmonary Hypertension Machine Learning-Based Notification Software	Class II	21 CFR 870.2380	3	0
SAW	Fluorescence Imaging For Breast Cancer Detection	Class III		0	1
SAX	Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device	Class II	21 CFR 886.1600	1	0
SAZ	Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb	Class III		0	0
SBA	Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate	Class II	21 CFR 862.1357	2	0
SBB	System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection	Class III		0	1
SBC	Dental Image Analyzer	Class II	21 CFR 872.1770	1	0
SBE	Digital Physical/Chemical Sterilization Process Sensor	Class II	21 CFR 880.2801	1	0
SBF	Orthopedic Augmented Reality	Class II	21 CFR 882.4560	43	2
SBG	In Situ Polymerizing Peripheral Nerve Cap	Class II	21 CFR 882.5260	2	0
SBH	Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter	Class II	21 CFR 862.1355	3	0
SBI	Manual Refractor, 3d Display	Class I	21 CFR 886.1770	1	0
SBK	Artificial Chordae Tendineae Surgical Replacement System	Class II	21 CFR 870.3490	1	0
SBL	Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4	Class III	21 CFR 864.1860	0	0
SBN	Digital Therapy Device For Convergence Insufficiency	Class I	21 CFR 886.1290	1	0
SBO	Bed-Patient Activity Monitoring System	Class I	21 CFR 880.2400	1	0
SBP	Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test	Class II	21 CFR 866.3171	1	0
SBQ	Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software	Class II	21 CFR 870.2380	2	0
SBS	Laryngeal Injection Set With Led Light	Class I	21 CFR 874.4420	1	0
SBT	Device To Detect Microbial Colonization Directly From Clinical Specimens.	Class II	21 CFR 866.3967	1	0
SBX	Software For Endoscopy Procedure Metrics	Class II	21 CFR 876.1500	0	0
SBY	High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids	Class II	21 CFR 866.6085	1	0
SBZ	Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users	Class II	21 CFR 866.3986	1	0
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Class II	21 CFR 866.3987	12	0
SCB	Deflation Needle For Removal Of Intragastric Balloon	Class II	21 CFR 876.1550	0	0
SCE	Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule	Not classified		0	0
SCF	Ldt, Unmet Need Within An Integrated Healthcare System	Not classified		0	0
SCG	Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule	Not classified		0	0
SCH	Ldt, Approved By Nys Clep	Not classified		0	0
SCI	Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule	Not classified		0	0
SCJ	Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule	Not classified		0	0
SCK	Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd	Not classified		0	0
SCL	Allergen And Vaccine Delivery Needles	Class II	21 CFR 880.5570	25	0
SCN	Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief	Class II	21 CFR 882.5870	1	0
SCP	Computerized Behavioral Therapy Device For Anxiety Disorders	Class II	21 CFR 882.5801	1	0
SCR	Air-Conduction Hearing Aid Software	Class II	21 CFR 874.3335	5	0
SCS	Ultraviolet Radiation Disinfection Chamber Device	Class II	21 CFR 880.6511	2	0
SCT	Foley Catheters And Accessories With Additional Safety Features	Class II	21 CFR 876.5130	0	0
SCU	Dna And Rna Oncology Controls	Class II	21 CFR 866.5910	0	0
SCV	Modular Electromechanical Surgical System	Class II	21 CFR 878.4964	4	1
SCW	Digital Prismatic Correction	Class I	21 CFR 886.1655	2	0
SCX	Immunoassay For Host Biomarkers Of Sepsis	Class II	21 CFR 866.3215	1	0
SCY	Sacroiliac Joint Guidewire Placement Device	Class II	21 CFR 888.3040	1	0
SCZ	Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures	Class II	21 CFR 870.1254	1	1
SDA	Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer	Class III		0	0
SDB	Tracheal Prosthesis With Cover Material Derived From Human Sources	Class II	21 CFR 868.3721	1	0
SDC	Qualitative Cleaning Process Protein Indicator	Class II	21 CFR 880.6930	1	2
SDD	Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field	Class II	21 CFR 878.4965	5	0
SDE	Light Based Device For Dry Age-Related Macular Degeneration	Class II	21 CFR 886.5520	1	1
SDG	Brain Intraparenchymal Infusion Cannula	Class II	21 CFR 882.4110	1	0
SDJ	Adjunctive Cardiac Amyloidosis Status Indicator	Class II	21 CFR 870.2200	3	0
SDK	Transdermal Test For Assessment Of Glomerular Filtration Rate	Class III		0	0
SDL	Transvenous Temporary Phrenic Nerve Stimulator	Class III		0	0
SDM	Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps	Unclassified		0	0
SDN	Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps	Unclassified		0	0
SDO	Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation	Class II	21 CFR 890.5851	4	0
SDP	Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit	Class II	21 CFR 864.1861	1	0
SDQ	Alfapump System	Class III		0	0
SDS	Compression-Based Airway Clearance Device	Class II	21 CFR 868.5665	0	0
SDT	Intra-Pulmonary Percussive Vibration (Ipv) Devices	Class II	21 CFR 868.5665	3	0
SDV	Clinical Electronic Thermometer	Class II	21 CFR 880.2910	0	0
SDW	Stationary Infrared Thermometer	Class II	21 CFR 880.2910	0	0
SDX	Neuromuscular Stimulator And Exercise Evaluation System	Class II	21 CFR 882.1871	1	0
SDY	Loss Of Pulse Notification Software	Class II	21 CFR 870.2790	1	0
SDZ	Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions	Class III		0	0
SEA	Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users	Class II	21 CFR 866.3386	1	0
SEC	Wearable Fall Injury Prevention Device	Class II	21 CFR 890.3780	1	0
SEE	Computerized Behavioral Therapy Device For Migraine	Class II	21 CFR 882.5806	1	0
SEF	Central Venous Catheter With Manual Insertion System	Class II	21 CFR 880.5200	1	0
SEG	Leadless Cardiac Resynchronization Therapy (Crt)	Class III		0	0
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Class II	21 CFR 866.3173	4	0
SEJ	Wound Dressings Containing Topical Analgesics	Unclassified		6	0
SEK	Wound Dressings With Hydrocortisone	Unclassified		2	0
SEL	Securement Wound Dressing For Reduction Of Infection	Unclassified		3	0