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 65 of 71

FDA product codes, page 65 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
QLU	Anti-Factor Xa Activity Test System, Apixaban	Class II	21 CFR 864.7295	3	1
QLV	Field Generator Positioning Device	Class I	21 CFR 882.4565	0	0
QLW	Covid-19 Test Home Collection Kit Devices	Not classified		0	1
QLX	Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna	Class II	21 CFR 866.3183	4	0
QLY	Ophthalmic Syringe	Class II	21 CFR 880.5860	7	0
QLZ	Septostomy Catheter, Reprocessed	Class II	21 CFR 870.5175	2	0
QMA	Blood Collection Device For Cell-Free Nucleic Acid	Class II	21 CFR 862.1676	2	0
QMC	Transport Medium, Notified Per The Vtm Guidance	Class I	21 CFR 866.2390	0	4
QMD	Transcranial Magnetic Stimulation System For Smoking Cessation	Class II	21 CFR 882.5802	2	0
QME	Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate	Class II	21 CFR 870.2785	13	0
QMF	Mask, Surgical, Eua Authorized	Not classified		0	0
QMG	Shockwave Intravascular Lithotripsy System	Class III		0	0
QMI	Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna	Class II	21 CFR 866.3183	2	0
QMJ	Powered Radiofrequency Toothbrush	Class II	21 CFR 872.6866	2	0
QML	Anal Fistula Closure Device	Class II	21 CFR 878.4835	1	0
QMM	Hydrophilic Re-Coating Solution	Class II	21 CFR 886.5919	1	0
QMN	Covid-19 Multi-Analyte Antigen Device	Not classified		0	7
QMS	Adjunctive Open Loop Fluid Therapy Recommender	Class II	21 CFR 870.5600	2	0
QMT	Prep Kit – Vaccine Injection	Class II	21 CFR 880.5570	0	1
QMV	Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness	Class II	21 CFR 866.3966	3	0
QMW	Coronary Artery Disease Risk Indicator From Acoustic Heart Signals	Class II	21 CFR 870.1420	1	0
QMX	Label Or Tag, Non-Sterile	Class I	21 CFR 878.4800	0	0
QMY	Computerized Behavioral Therapy Device For Treating Symptoms	Class II	21 CFR 876.5960	3	0
QMZ	Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions	Class II	21 CFR 882.5705	1	0
QNA	Ultrasonic Urinary Stone Propulsion Device	Class II	21 CFR 876.4690	2	0
QNB	Plasma Processing System For Converting Alpha To Pre-Beta High-Density Lipoprotein	Humanitarian device exemption		0	0
QNC	Whole Exome Sequencing Constituent Device	Class II	21 CFR 866.6000	1	0
QNE	Endoscopic Pancreatic Debridement Device	Class II	21 CFR 876.4330	1	0
QNF	Laser Activator For Polymerization	Class II	21 CFR 872.6070	2	0
QNH	Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay	Class III	21 CFR 864.1860	0	0
QNI	Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair	Class II	21 CFR 888.3044	3	2
QNJ	Mass Spectrometry, Microorganism Identification, Blood Culture	Class II	21 CFR 866.3378	2	0
QNK	Optoacoustic Imaging System	Class III		0	0
QNL	Medium-Term Adjunctive Predictive Cardiovascular Indicator	Class II	21 CFR 870.2210	6	0
QNM	Mountable Electromechanical Surgical System For Transluminal Approaches	Class II	21 CFR 878.4961	8	0
QNN	Prosthesis, Total Talus Replacement, Metal	Humanitarian device exemption		0	0
QNO	Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea	Class II	21 CFR 872.5575	3	0
QNP	Gastrointesinal Lesion Software Detection System	Class II	21 CFR 876.1520	23	0
QNQ	Low Dead Space Piston Syringe	Class II	21 CFR 880.5860	12	0
QNR	Blood Pump For Ecmo, Long-Term (> 6 Hours) Use	Class II	21 CFR 870.4100	8	2
QNS	Low Dead Space Needle, Single Lumen, Hypodermic	Class II	21 CFR 880.5570	3	0
QNU	Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion	Class II	21 CFR 874.6000	1	0
QNV	Adjunctive Hemodynamic Indicator With Decision Point	Class II	21 CFR 870.2220	3	0
QNW	Reprocessed Bronchoscope	Class II	21 CFR 874.4680	2	1
QNX	External Compression Device For Internal Jugular Vein Compression	Class II	21 CFR 890.3050	1	0
QNY	Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring	Not classified		0	0
QNZ	Powered Communication System For Emergency Use	Not classified		0	0
QOA	Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening	Not classified		0	0
QOC	Temporary Non-Roller Type Left Or Right Heart Support Blood Pump	Not classified		0	0
QOD	Extracorporeal Circuit And Accessories For Long Term Respiratory Cariodpulmonary Failure	Not classified		0	0
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Class II	21 CFR 866.3981	36	9
QOG	Injection Data Capture Device	Class II	21 CFR 880.5860	7	0
QOH	Extracorporeal System For Carbon Dioxide Removal	Class II	21 CFR 870.4150	1	0
QOI	Intravenous Catheter Force-Activated Separation Device.	Class II	21 CFR 880.5220	8	0
QOJ	Apparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only)	Not classified		0	0
QOK	Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate	Class II	21 CFR 870.2786	2	0
QOL	Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser	Class II	21 CFR 890.5420	1	0
QON	Implanted Electrical Device Intended For Treatment Of Fecal Incontinence	Class III	21 CFR 876.5270	0	0
QOO	Ventilator Tubing And Accessories	Not classified		0	0
QOP	Respiratory Humidifier For Emergency Use	Not classified		0	0
QOQ	Non-Continuous Ventilator For Emergency Use	Not classified		0	0
QOR	Continuous Ventilator, Minimal Ventilatory Support	Not classified		0	0
QOS	Continuous Ventilator	Not classified		0	1
QOT	Emergency Ventilator	Not classified		0	0
QOU	Emergency Resuscitator	Not classified		0	0
QOV	Critical Care Ventilator	Not classified		0	0
QOW	Ventilatory Assistance Helmet	Not classified		0	0
QOX	Multi-Patient Circuit Connector	Not classified		0	0
QOZ	Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy	Not classified		0	0
QPB	System, Suction, Lipoplasty For Removal	Class II	21 CFR 878.5040	60	1
QPC	Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection	Class II	21 CFR 878.4040	12	0
QPD	Personal Lubricant Ring	Class II	21 CFR 884.5300	1	0
QPE	Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions	Class II	21 CFR 878.4880	1	0
QPF	Pediatric Autism Spectrum Disorder Diagnosis Aid	Class II	21 CFR 882.1491	6	0
QPK	Eua Faceshields	Not classified		0	0
QPL	Electromagnetic Stimulator, Pain Relief	Class II	21 CFR 882.5890	6	0
QPN	Software Algorithm Device To Assist Users In Digital Pathology	Class II	21 CFR 864.3750	2	0
QPO	Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples	Class II	21 CFR 866.2952	1	6
QPP	Implantable Post-Surgical Kinematic Measurement Knee Device	Class II	21 CFR 888.3600	4	1
QPQ	Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed	Class II	21 CFR 888.3630	1	0
QPR	Neurological Stimulation For Emergency Use	Not classified		0	0
QPS	Immunoassay For Host Biomarkers Of Infection	Class II	21 CFR 866.3215	4	0
QPT	Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence	Class III		0	0
QPW	Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube	Not classified		0	0
QPX	Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical	Class II	21 CFR 878.4683	1	0
QPY	Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation	Class III		0	0
QPZ	Contact Cooling For Skin Lesion Pain Relief	Class II	21 CFR 878.4340	2	0
QQB	Prognostic Test For Assessment Of Liver Related Disease Progression	Class II	21 CFR 862.1622	1	0
QQC	Brain Stimulation Programming Planning Software.	Class II	21 CFR 882.5855	3	0
QQE	Image Management Software For Planning Of Otologic And Neurotologic Procedures	Class II	21 CFR 892.2050	3	0
QQF	Skin Microneedling Manual/Automated Device (Export Only)	Not classified		0	0
QQG	Oropharyngeal Electrical Stimulator	Class II	21 CFR 874.5950	1	0
QQH	Powered Insertion System For A Cochlear Implant Electrode Array	Class II	21 CFR 874.4450	2	1
QQI	Interventional Cardiovascular Implant Simulation Software Device	Class II	21 CFR 870.1405	4	0
QQJ	Applicator, Negative Pressure, External, Ocular	Class II	21 CFR 886.5000	2	0
QQK	Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation	Class III		0	1
QQO	Cranial Measurement Software	Class I	21 CFR 878.4800	1	0
QQQ	Guide And Positioner, Ophthalmic Drug Delivery Device	Class I	21 CFR 886.4300	0	0
QQR	Circumcision Device With Stapler	Class II	21 CFR 884.4530	0	0
QQS	Stapler, Skin	Class I	21 CFR 878.4740	0	0