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 67 of 71

FDA product codes, page 67 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
QVR	Multiplex Nucleic Acid Detection System For Biothreat Agents	Class II	21 CFR 866.4000	3	0
QVS	Breast Implant Suction Retrieval Device	Class II	21 CFR 878.4675	2	0
QVT	Monitor For Opioid Induced Impairment Of Oxygenation	Class II	21 CFR 868.2250	1	0
QVU	High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.	Class II	21 CFR 866.6095	1	0
QVV	Medial Knee Implanted Shock Absorber	Class II	21 CFR 888.3610	1	1
QVW	Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led	Not classified		0	0
QVX	Skin Patch For Treatment Of Hyperhidrosis	Class II	21 CFR 878.4425	1	0
QVY	Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome	Class II	21 CFR 880.5151	1	0
QWA	Cardiovascular Delivery Catheter System Positioning And Stabilization Device	Class I	21 CFR 870.3955	0	0
QWB	Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens	Class II	21 CFR 866.3984	3	1
QWC	Pulmonary Stent	Class III		0	0
QWD	Stimulator, Nerve, For Restless Legs Syndrome	Class II	21 CFR 882.5887	1	0
QWE	Hyperoxia Monitoring Device Adjunct To Pulse Oximetry	Class II	21 CFR 870.2720	1	0
QWF	Tubing, Long Term Support Greater Than 6 Hours	Class II	21 CFR 870.4100	1	0
QWH	Prognostic Test For Development Or Progression Of Preeclampsia	Class II	21 CFR 862.1602	2	1
QWI	Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms	Class II	21 CFR 882.5804	1	0
QWJ	Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament	Class II	21 CFR 878.3300	1	0
QWK	Prosthesis, Posterior Spinal Elements	Class III		0	1
QWL	Intraoperative Surgical Angle Measurement Tool	Class II	21 CFR 888.4560	3	0
QWM	Stent Graft, Bypass, Superficial Femoral Artery	Class III		0	0
QWN	Stent Graft, Infrapopliteal, Venous Arterialization	Class III		0	0
QWO	Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.	Class II	21 CFR 892.2085	4	0
QWP	Optical Neurosurgical Nerve Locator	Class II	21 CFR 874.1820	1	0
QWQ	Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors	Class III		0	0
QWR	Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings	Class II	21 CFR 866.3982	3	2
QWS	Foam Or Gel Chemical Sterilant/High Level Disinfectant	Class II	21 CFR 880.6886	2	0
QWT	Prognostic Assessment Software Of Mild Cognitive Impairment	Class II	21 CFR 882.1454	1	0
QWU	Prosthesis, Eyelid Spacer/Graft, Polymer	Class II	21 CFR 886.3130	1	3
QWW	Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.	Class II	21 CFR 876.5021	1	0
QWX	Active Noise Attenuation System For Infant Incubators	Class II	21 CFR 880.5405	1	0
QWY	Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator	Class III		0	0
QWZ	Prognostic Test For Assessment Of Chronic Kidney Disease Progression	Class II	21 CFR 862.1223	1	3
QXA	Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection	Class II	21 CFR 866.3230	2	0
QXB	Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia	Class III		0	0
QXC	Diabetes Digital Therapeutic Device	Class II	21 CFR 880.5735	1	0
QXD	Spinal Imaging System For Neuraxial Procedures	Class II	21 CFR 868.1985	1	0
QXG	Cooperative Powered Surgical Assist Device For Ent Surgery	Class II	21 CFR 874.4460	1	0
QXH	Gallbladder Drainage Stent And Delivery System	Class II	21 CFR 876.5016	1	0
QXJ	Whole Room Microbial Reduction Device	Class II	21 CFR 880.6510	2	1
QXL	Cabinet, Emission Computed Tomography System	Class II	21 CFR 892.1200	1	0
QXM	Implanted Tibial Electrical Urinary Continence Device	Class II	21 CFR 876.5305	4	0
QXN	Suction Anti-Choking Device As A Second-Line Treatment	Class II	21 CFR 874.5400	1	0
QXO	Cardiovascular Machine Learning-Based Notification Software	Class II	21 CFR 870.2380	2	0
QXQ	Respiratory Accessory Microbial Reduction Device.	Class II	21 CFR 880.6993	3	2
QXR	Vaginal Hydrogel Packing System	Class II	21 CFR 892.5735	1	0
QXS	Chromogranin A	Class II	21 CFR 866.6010	1	0
QXT	Infliximab Test System	Class II	21 CFR 862.3115	1	0
QXU	Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation	Class II	21 CFR 870.5710	2	0
QXV	Temperature Regulation Device For Esophageal Protection During Cardiac Ablation	Class II	21 CFR 870.5720	1	0
QXW	Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer	Class II	21 CFR 878.4355	1	0
QXX	Coronary Artery Disease Machine Learning-Based Notification Software	Class II	21 CFR 870.2380	1	0
QXY	Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature	Class II	21 CFR 870.1135	1	0
QXZ	Adjunctive Epicardial Vascular Physiologic Status Indicator	Class II	21 CFR 870.2200	1	0
QYA	System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home	Class II	21 CFR 866.3385	2	0
QYC	Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions	Class II	21 CFR 864.9115	0	0
QYD	Adalimumab Assay	Class II	21 CFR 862.3115	1	0
QYE	Reduced Ejection Fraction Machine Learning-Based Notification Software	Class II	21 CFR 870.2380	5	0
QYF	Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)	Class II	21 CFR 870.1130	0	0
QYI	Ablation Catheter, Renal Denervation	Class III		0	2
QYJ	Dental Waterline Treatment Cartridge	Class I	21 CFR 872.6640	1	0
QYK	Semi-Automated Autologous Skin Graft Harvesting And Application Device	Class II	21 CFR 878.4795	1	0
QYM	Ophthalmic Needle	Class II	21 CFR 880.5570	2	0
QYN	Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)	Class I	21 CFR 890.5775	1	0
QYO	Hematopoietic Cell Enrichment Kit	Class II	21 CFR 866.6120	1	0
QYQ	Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal	Humanitarian device exemption		0	0
QYT	Over-The-Counter Covid-19 Antigen Test	Class II	21 CFR 866.3984	14	3
QYU	Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use	Class II	21 CFR 870.2705	2	0
QYV	Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm	Class II	21 CFR 864.3900	1	1
QYW	Hospital Cardiac Telemetry	Class II	21 CFR 870.1025	2	0
QYX	Outpatient Cardiac Telemetry	Class II	21 CFR 870.1025	21	0
QYZ	At Home Intravaginal Insemination System	Class II	21 CFR 884.6110	3	0
QZA	Body Temperature Sensing Software	Class II	21 CFR 880.2915	2	0
QZB	Software Controlled Endoscope And Instrument Holder	Class II	21 CFR 876.1500	4	0
QZC	External Mechanical Stimulator For The Relief Of Congestion	Class II	21 CFR 874.6010	2	0
QZF	Gastrointestinal Capsule Endoscopy Analysis Software Device	Class II	21 CFR 876.1540	3	0
QZG	Menstrual Blood Collection Device	Class II	21 CFR 862.1675	0	0
QZH	Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit	Class III		0	0
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Class III		0	6
QZJ	Immunohistochemistry Assay, Antibody, Claudin 18	Class III	21 CFR 864.1860	0	0
QZK	Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions	Class III		0	0
QZL	Post-Ablation Tissue Response Prediction Software	Class II	21 CFR 892.2052	2	0
QZN	Multi-Photon Imaging	Class II	21 CFR 878.4580	1	0
QZO	Wearable Vibration Device For Orthopedic Use	Class II	21 CFR 888.5895	1	0
QZP	Camera, Ophthalmic, Non-Prescription	Class II	21 CFR 886.1120	0	0
QZS	Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer	Class II	21 CFR 878.1830	1	1
QZT	Gowns And Other Apparel	Not classified		0	0
QZU	Temporary Embolization Assist Device, Peripheral	Class II	21 CFR 870.3325	1	0
QZV	Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury	Class III		0	0
QZW	Over-The-Counter Device To Assess Risk Of Sleep Apnea	Class II	21 CFR 868.2378	3	0
QZX	Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing	Class II	21 CFR 866.1650	3	0
QZY	Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating	Class II	21 CFR 888.3071	1	0
QZZ	Limb And Joint Salvage Device With Coating For Bacteria Reduction	Class II	21 CFR 888.3900	3	0
RAA	Laser Products (Pre-Standard)	Not classified		0	0
RAB	Sunlamp Products (Pre-Standard)	Class II	21 CFR 878.4635	0	0
RAC	Nondestructive Tests	Not classified		0	0
RAD	Gauging	Not classified		0	0
RAE	Ranging	Not classified		0	0
RAF	Cleaner	Not classified		0	0
RAG	Welder	Not classified		0	0
RAH	Jewelry Cleaner	Not classified		0	0