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 62 of 71

FDA product codes, page 62 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
PXK	Vascular Access Port Kit	Class II	21 CFR 880.5965	0	0
PXL	Venipuncture Kit	Class II	21 CFR 880.5570	0	0
PXM	Vomitus Clean-Up Kit	Class I	21 CFR 880.6890	0	0
PXN	Basic Set-Up Tray	Class I	21 CFR 878.4800	0	0
PXO	Bone Marrow Biopsy Tray	Class I	21 CFR 878.4800	0	3
PXP	Breast Biopsy / Localization Tray	Class I	21 CFR 878.4800	0	8
PXQ	Burn Dressing Tray	Class I	21 CFR 878.4022	0	0
PXR	Cement And Bone Removal Kit	Class I	21 CFR 878.4820	0	0
PXS	Cholecystectomy Kit	Class I	21 CFR 878.4800	0	0
PXU	Fluid Drainage Tray	Class I	21 CFR 878.4200	0	1
PXV	General Purpose Instrument Tray	Class I	21 CFR 878.4800	0	0
PXW	Herniorraphy Kit	Class I	21 CFR 878.4800	0	0
PXX	Incision Tray	Class I	21 CFR 878.4800	0	0
PXY	Irrigation Kit (Wounds)	Class I	21 CFR 878.4014	0	0
PXZ	Laparascopic Sphincterotomy Kit	Class I	21 CFR 878.4800	0	0
PYA	Liver Biopsy Kit	Class I	21 CFR 878.4800	0	0
PYB	Minor Surgical Procedures Tray	Class I	21 CFR 878.4800	0	0
PYC	Paracentesis Tray	Class I	21 CFR 878.4200	0	6
PYD	Pelviscopy Kit	Class I	21 CFR 878.4800	0	0
PYE	Staple Removal Kit	Class I	21 CFR 878.4760	1	0
PYF	Sterile Puncture Tray	Class I	21 CFR 878.4800	0	0
PYG	Suction Catheter Kit	Class I	21 CFR 878.4200	0	0
PYH	Surgical Retractor Kit	Class I	21 CFR 878.4800	0	0
PYI	Thoracic Catheter Insertion Tray	Class I	21 CFR 878.4200	0	1
PYJ	Ulcer Wound Tray	Class I	21 CFR 878.4014	0	0
PYK	Venous Ulcer Kit	Class I	21 CFR 878.4014	0	0
PYL	Wound Drainage Kit	Class I	21 CFR 878.4014	0	0
PYN	Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.	Class II	21 CFR 866.3367	1	0
PYO	Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use	Class I	21 CFR 880.5240	1	0
PYP	Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test	Class I	21 CFR 862.1475	1	0
PYQ	Rfid Chip For Dental Appliance	Class II	21 CFR 880.6300	1	0
PYR	Neuraxial Administration Set - Intrathecal Delivery	Class II	21 CFR 880.5440	0	0
PYS	Zika Virus Serological Reagents (Emergency Use)	Not classified		0	0
PYT	Device, Fertility Diagnostic, Contraceptive, Software Application	Class II	21 CFR 884.5370	7	0
PYU	Sponge, Eyelid Cleaning, Powered	Class I	21 CFR 878.4820	0	0
PYV	Hospital Continuous Glucose Monitoring System	Class II	21 CFR 862.1345	0	0
PYX	Temporary Non-Roller Type Right Heart Support Blood Pump	Class III	21 CFR 870.4360	0	7
PZC	Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue	Not classified		0	0
PZE	Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated	Class III		0	3
PZF	Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System	Class II	21 CFR 866.4001	1	0
PZG	Surgical Eye Tray	Class I	21 CFR 886.4350	0	6
PZH	Serpina1 Variant Detection System	Class II	21 CFR 866.5130	3	0
PZI	Prescription Use Blood Glucose Meter For Near-Patient Testing	Class II	21 CFR 862.1345	14	6
PZJ	Lynch Syndrome Test System	Class II	21 CFR 864.1866	4	0
PZK	Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)	Class III	21 CFR 886.3600	0	0
PZL	Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	Class II	21 CFR 878.4685	8	0
PZM	Next Generation Sequencing Based Tumor Profiling Test	Class II	21 CFR 866.6080	8	0
PZN	Placental Growth Factor Test	Not classified		0	0
PZO	Software For Visualization Of Vascular Anatomy And Intravascular Devices	Class II	21 CFR 892.2050	10	0
PZP	Fluid Jet Removal System	Class II	21 CFR 876.4350	9	2
PZQ	General Laparoscopic Power Morcellation Containment System	Class II	21 CFR 878.4825	1	0
PZR	Percutaneous Nerve Stimulator For Opioid Withdrawal	Class II	21 CFR 882.5896	8	1
PZS	Dual Lumen Ecmo Cannula	Class II	21 CFR 870.4100	4	0
PZT	Peripheral Blood Processing Device For Osteoarthritis	Not classified		0	0
PZU	Bone Marrow Processing Device For Clinical Use	Not classified		0	0
PZV	Peripheral Blood Processing Device For Clinical Use	Not classified		0	0
PZW	Catheter Access Cover, Tamper-Resistant	Class II	21 CFR 880.5970	2	0
PZX	Left Atrial Appendage Clip, Implantable	Class II	21 CFR 878.4300	10	0
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Class II	21 CFR 872.3590	1	0
PZZ	Digital Pathology Display	Class II	21 CFR 864.3700	3	0
QAA	Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens	Class II	21 CFR 866.3376	1	0
QAB	Pacing System Analyzer	Class II	21 CFR 870.3605	0	0
QAC	Screw Sleeve Bone Fixation Device	Class II	21 CFR 888.3043	1	0
QAD	Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated	Class II	21 CFR 888.3023	7	0
QAF	Impedance Plethysmograph, Cranial	Class II	21 CFR 870.2770	3	0
QAG	Endoscopic Electrosurgical Clip Cutting System	Class II	21 CFR 876.4310	1	0
QAI	Powered Microneedle Device	Class II	21 CFR 878.4430	26	3
QAJ	Cutaneous Electrode Stimulator For Urinary Incontinence	Class II	21 CFR 876.5330	5	0
QAK	Non-Invasive Vagus Nerve Stimulator For Migraine Headache	Class II	21 CFR 882.5892	0	0
QAN	Stent, Iliac Vein	Class III		0	9
QAQ	Adjunctive Predictive Cardiovascular Indicator	Class II	21 CFR 870.2210	5	0
QAR	Thermal Vestibular Stimulator For Headache	Class II	21 CFR 882.5893	1	0
QAS	Radiological Computer-Assisted Triage And Notification Software	Class II	21 CFR 892.2080	88	0
QAT	Brain Trauma Assessment Test	Class II	21 CFR 866.5830	6	0
QAU	Hemostatic Device For Endoscopic Gastrointestinal Use	Class II	21 CFR 878.4456	12	8
QAV	High Flow/High Velocity Humidified Oxygen Delivery Device	Class II	21 CFR 868.5454	3	1
QAW	Test, Tricyclic Antidepressants, Over The Counter	Class II	21 CFR 862.3910	0	0
QAX	Hemodialyzer With Expanded Solute Removal Profile	Class II	21 CFR 876.5862	2	0
QAZ	Cancer Predisposition Risk Assessment System	Class II	21 CFR 866.6090	4	0
QBA	Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation	Class III		0	0
QBB	Placental Alpha Microglobulin-1 Immunoassay	Class III		0	0
QBC	External Upper Limb Tremor Stimulator	Class II	21 CFR 882.5897	9	0
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Class II	21 CFR 866.2950	17	7
QBE	Cranial Sound Monitor	Class II	21 CFR 870.1875	1	0
QBF	Test, Propoxyphene, Over The Counter	Class II	21 CFR 862.3700	1	0
QBG	Assay, Oral Direct Thrombin Inhibitor	Not classified		0	0
QBH	Lower Respiratory Microbial Nucleic Acid Detection System	Class II	21 CFR 866.3985	2	4
QBI	Acute Coronary Syndrome Event Detector	Class III		0	1
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Class II	21 CFR 862.1355	18	23
QBK	Meprobamate Test System	Class II	21 CFR 862.3590	2	0
QBL	Piston Syringe Lever	Class II	21 CFR 880.5860	3	0
QBN	Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Class II	21 CFR 866.3378	4	0
QBO	Instruments Designed For Press-Fit Osteochondral Implants	Class II	21 CFR 888.4505	2	0
QBP	Cap, Device Disinfectant	Class II	21 CFR 880.5440	22	2
QBQ	System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture	Class I	21 CFR 866.2560	1	0
QBR	Intranasal Electrostimulation Device For Dry Eye Symptoms	Class II	21 CFR 886.5310	2	0
QBS	Radiological Computer Assisted Detection/Diagnosis Software For Fracture	Class II	21 CFR 892.2090	11	0
QBT	Artificial Iris	Class III		0	0
QBV	Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate	Class I	21 CFR 862.2050	2	0
QBW	Surgical Apparel With Material Claims	Class II	21 CFR 878.4040	1	0