510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 2512 of 3531

510(k) clearances, page 2512 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K902519	Eye Spy Sunglasses	E. M. Intl. Products, Ltd.	HQY	Class I	1990-09-24
K901413	Core Disposable Insufflation Tubing	Core Dynamics, Inc.	HES	Class II	1990-09-24
K904232	Boston(r) Brand Latex Exam Gloves/hypoallergenic	Boston Medical Corp.	LYY	Class I	1990-09-21
K903901	Scanning Cot	Med-Tron Products, Inc.	IYZ	Class I	1990-09-21
K903728	Synermed Direct Bilirubin Reagent Kit	Synermed, Inc.	CIG	Class II	1990-09-21
K903377	Computerized Tomography X-Ray System Option	Siemens Medical Solutions USA, Inc.	JAD	Class II	1990-09-21
K903200	Minicap III CO2 Detector	Minesafety Appliances Co.	CCK	Class II	1990-09-21
K902937	Milenia Pap Irma Catalog #: Mkpa1, X	Siemens Healthcare Diagnostics Inc.	JFH	Class II	1990-09-21
K902330	E-Z Flo + Set	Prn Services, Inc.	FPA	Class II	1990-09-21
K902217	Temporomandibular Joint (Tmj) Coil	Siemens Medical Solutions USA, Inc.	LNH	Class II	1990-09-21
K900856	Ven-O-Vac Blood Collection Vacuum Tubes	Artefactos de Vidrio S.A. de C.V.	JKA	Class II	1990-09-21
K895543	Wigness-Buchwald Central Venous Access Catheter	Strato Medical Corp.	LJS	Class II	1990-09-21
K895024	Punctur-Guard(tm) Blood Collection Needle	Bio-Plexus, Inc.	FMI	Class II	1990-09-21
K903812	Electroprobe Single-Use Surgical Probe	Ximed Medical Systems	GEI	Class II	1990-09-20
K903689	Coherent Diode Photocoagulator	Lumenis Ltd	GEX	Class II	1990-09-20
K903412	Storz Model M705 And/or M706 Ceiling Mounted Micr.	Storz Instrument Co.	EPT	Class I	1990-09-20
K903006	Electrosurgical Bipolar Forceps	Megadyne Medical Products, Inc	GEI	Class II	1990-09-20
K902855	New Jersey Total Shoulder Glenoid Component	Depuy, Inc.	KWS	Class II	1990-09-20
K902818	Multiple Nonpowered Neurosurgical Instrument	Ruggles Corp.	HBG	Class II	1990-09-20
K902763	Sterile Instrument Drape	North American Sterilization & Packaging Co.	HMW	Class II	1990-09-20
K902663	Ge Quadrature T/l Spine Surf Coil, M1085ap/m1285ap	General Electric Co.	LNH	Class II	1990-09-20
K902544	Sundt Avm Micro Clip	Cerenovus, Inc.	HCI	Class II	1990-09-20
K902274	Customed Cysto Pack I	Customed, Inc	FAJ	Class II	1990-09-20
K902005	Model B-200 C-Arm & Model C-300 Cardiac Table	Omega Medical Imaging, LLC	JAA	Class II	1990-09-20
K901710	Optica 120 Nd:yag Surgical Laser System	Xintec Corporation	GEX	Class II	1990-09-20
K896408	Quantum	Stressmaster Systems, Inc.	GZJ	Class II	1990-09-20
K904190	Patient Examination Gloves	1st Med, Inc.	LYY	Class I	1990-09-19
K904152	S.p.f. Premier 2 Wheelchair	Everest & Jennings, Inc.	IOR	Class I	1990-09-19
K903883	Vasculase(r) Copper Vapor Laser Syst, Pigment Les	Metatech Corp.	GEX	Class II	1990-09-19
K903820	Thera-Cane	Pro Message Co.	LYG	Class I	1990-09-19
K903678	Argenco 8 Gold Alloy for Porcelain	Argen Precious Metals, Inc.	EJT	Class II	1990-09-19
K903447	Sterile Latex Examination Gloves	Sime Darby USA	LYY	Class I	1990-09-19
K903414	Transesophageal Probe Holder & Disinfecting Column	Echo Ultrasound	DXK	Class II	1990-09-19
K903143	Otoscreener-I and Oto-Screen-I-P	Handtronix, Inc.	EWO	Class II	1990-09-19
K903080	Disposable Plastic Vaginal Speculum	Dawnex Industries, Inc.	HIB	Class II	1990-09-19
K903007	Mircas Dental Cartridge Syringe and Mircas Cover	Habley Medical Technology Corp.	EJI	Class II	1990-09-19
K902886	Customed Basic Pack III	Customed, Inc	KKX	Class II	1990-09-19
K902885	Customed Basic Pack II	Customed, Inc	KKX	Class II	1990-09-19
K902884	Customed Basic Pack I	Customed, Inc	KKX	Class II	1990-09-19
K902790	Napa	G-Ortho Lab	LQZ	Class II	1990-09-19
K902714	Latex Surgical Gloves (Yuetong Enterprise Co. Ltd)	Quinhuangda Yuetong Ent. Co., Ltd.	KGO	Class I	1990-09-19
K902658	Gynescope Monopolar Forceps and Electrodes	Gynescope Corp.	KNF	Class II	1990-09-19
K902657	Gynescope Laparoscopic Forceps	Gynescope Corp.	HET	Class II	1990-09-19
K902432	Ambulatory Infuser and Assoc. Flow Controlling Set	Abbott Medical	FRN	Class II	1990-09-19
K902258	5 Mm Irrigation/aspiration Fiber Probe	Hgm Medical Laser Systems, Inc.	HET	Class II	1990-09-19
K901701	Central Venous Access Catheter	Cardiopulmonics, Inc.	FOZ	Class II	1990-09-19
K901524	Chemfil II Caps	Dentsply Intl.	EMA	Class II	1990-09-19
K901085	Dorr Knee System	Intermedics Orthopedics	JWH	Class II	1990-09-19
K900907	Cartier Sunglasses, Must De	Cartier, Inc.	HQY	Class I	1990-09-19
K900808	Rapid Automatic Pneumoperitoneum-I	Trek Medical Products, Inc.	HIF	Class II	1990-09-19