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 2388 of 3531

510(k) clearances, page 2388 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915794	Ad-Hear	Hearing Components, Inc.	ESD	Class I	1992-03-12
K915390	3 Lead Extension with 2 Interlink Injection Sites	Baxter Healthcare Corporation	FPA	Class II	1992-03-12
K914921	Scm-3 and Accessories	Gaymar Industries, Inc.	IKY	Class I	1992-03-12
K913730	Aesculap Titanium Bone Plates	Aesculap Inc	KWQ	Class II	1992-03-12
K913408	Sterile Plastic Drape	Acacia Laboratories, Inc.	KKX	Class II	1992-03-12
K912399	Hearing Aid (All-in-the-Ear)	Carlson'S Heritage Hearing Aid Center	ESD	Class I	1992-03-12
K920603	Trace Magnesium - Arsenazo Reagent	Trace America, Inc.	JGJ	Class I	1992-03-11
K920419	Il Test Dat Cal/control Set D/e	Instrumentation Laboratory Co.	DLG	Class I	1992-03-11
K920411	Immulite Hlh	Cirrus Diagnostics, Inc.	CEP	Class I	1992-03-11
K920370	Isotypes Human Igg Subclass Eia Kit	Isotypes, Inc.	CGM	Class II	1992-03-11
K920337	Miles Lipase Sera-Pak Method	Kulzer GmbH	CHI	Class I	1992-03-11
K920216	Syn Elisa Micro Albumin	Elias U.S.A., Inc.	JIR	Class I	1992-03-11
K920170	Spectacle Frame	Sciara Intl., Inc.	HQZ	Class I	1992-03-11
K920160	Lh Gen III Self-Test/conceive	Ortho-Clinical Diagnostics, Inc.	CEP	Class I	1992-03-11
K920059	Ultrasafe	Ultrawin Sdn Bhd	LYY	Class I	1992-03-11
K920037	Osteo Compression Hip Screw	Osteo AG	HRC	Class II	1992-03-11
K920008	Il Test Immunoglobulin M (Igm)	Instrumentation Laboratory Co.	CGM	Class II	1992-03-11
K915825	Marathon 6K General-Purpose Centrifuge	Fisher Scientific Company L.L.C.	GKF	Class II	1992-03-11
K915813	Ackrad Ercp Contrast Delivery Set	Ackrad Laboratories	FGE	Class II	1992-03-11
K915785	Stc Diagnostics Benzoylecgonine Eia	Solarcare Technologies Corp,Inc.	JXO	Class II	1992-03-11
K915680	Amerlite Processing Center	Eastman Kodak Company	JJQ	Class I	1992-03-11
K915596	Biomodular Shoulder Humeral Head W/ Ionguard	Zimmer GmbH	KWT	Class II	1992-03-11
K915577	Impraflo Postoperative Autotransfusion Device	Impra, Inc.	CAR	Class II	1992-03-11
K915561	Zeiss Multiyag Laser	Carl Zeiss, Inc.	GEX	Class II	1992-03-11
K915408	Bipolar Endostasis Probe, Best (Tm)	Medical Devices Inc.	KNS	Class II	1992-03-11
K915381	Portable Oxygen Generator	Aequitron Medical, Inc.	CAW	Class II	1992-03-11
K915096	Neurofax EEG 5532	Nihon Kohden America Inc	GWQ	Class II	1992-03-11
K915067	Disposable Needle Counters & Disposable Systems	American Medical Corp.	MMK	Class II	1992-03-11
K915064	Disposable Cautery Abrasive Pad	American Medical Mfg., Inc.	KDC	Class I	1992-03-11
K914877	Il Test(tm) Urea Nitrogen	Instrumentation Laboratory Co.	CDQ	Class II	1992-03-11
K914456	Dentacolor(r) Cre-Active	Kulzer GmbH	EBF	Class II	1992-03-11
K914455	Sharplan Models 100 Series C02 Lasers/accessories	Sharplan Lasers, Inc.	GEX	Class II	1992-03-11
K914337	Gas Sampling Interfaces	Vital Signs, Inc.	CCK	Class II	1992-03-11
K913847	System 90 and System 90T	Datascope Corp.	DSP	Class II	1992-03-11
K913765	Yasargil Aneurysm Clips, Modification	Aesculap Inc	HCH	Class II	1992-03-11
K912629	Datascope System 95	Datascope Corp.	DSP	Class II	1992-03-11
K915557	Rich-Mar Model 510 Ultrasound	Rich-Mar Corp.	IMI	Class II	1992-03-10
K915548	Ionguard Titanium Modular Heads	Zimmer GmbH	LZY	Class II	1992-03-10
K920099	Gymman	Lumiscope Co., Inc.	DRT	Class II	1992-03-09
K915810	Mer Bag	Merced Medical, Inc.	BTM	Class II	1992-03-09
K915640	Voyagr Series of Deflectable Diagostic Ep Catheter	Arrhythmia Technologies, Inc.	DRF	Class II	1992-03-09
K915563	Diagnostic Ep Catheter	Arrhythmia Technologies, Inc.	DRF	Class II	1992-03-09
K915544	Laparoscopy Scissors	C.R. Bard Inc	GCJ	Class II	1992-03-09
K914995	Cordis Straight Ventricular Catheter	Cordis US Corp.	JXG	Class II	1992-03-09
K914562	Aseptic Dental Tech. Total Treatment System	Aseptic Dental Technologies, Inc.	DZM	Class I	1992-03-09
K914325	Root Canal Filling Cement	Confi-Dental Products Co.	KIF	Class II	1992-03-09
K913944	Nezhat/dorsey Hydro Dissection Pump & Accessories	American Surgical Instruments Corp.	HET	Class II	1992-03-09
K920558	Konica Direct Digitizer Kd-1000	Konica Corp.	KPR	Class II	1992-03-06
K920325	Rangeroller (Modified)	Excel Mobility Products, Inc.	ITI	Class II	1992-03-06
K920199	Head Coil Geometric Distor Spec for Vista Hpq Syst	Philips North America LLC	LNH	Class II	1992-03-06