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 1014 of 3531

510(k) clearances, page 1014 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K100647	A-Dec/w&h Synea Sonic Scaler Handpiece, Models Za-55, Za-55 L, Za-55 Lm, Za-55M, Sf1lm	A-dec, Inc.	ELC	Class II	2010-07-09
K100600	Prosthodontic Screwdriver , Model Ia-400	W & H DentalWerk Buermoos GmbH	EKX	Class I	2010-07-09
K100595	Ecleris Microstar Colposcope	Ecleris USA	HEX	Class II	2010-07-09
K100511	Cotec Dental Implant System	Cotec Implant Co., Ltd.	DZE	Class II	2010-07-09
K100434	Clave Neutron	Abbott Medical	FPA	Class II	2010-07-09
K100432	Polyfin Infusion Set, Models Mmt-165, Mmt-365, Mmt-366, Mmt-312S and Mmt-312L and Sof-Set Infusion Sets	Medtronic, Inc.	FPA	Class II	2010-07-09
K100428	Masimo Rainbow Set Radical 7R Pulse Co-Oximeter	Masimo Corporation	DQA	Class II	2010-07-09
K100405	Fora G90 Perform Blood Glucose Monitoring System	Taidoc Technology Corporation	CGA	Class II	2010-07-09
K093964	Venofer Pump	Renal Solutions, Inc.	KDI	Class II	2010-07-09
K092853	3 Channel Digital Ambulatory ECG Recorder Model Galix Gbi-3Sm	Galix Biomedical Instrumentation, Inc.	MLO	Class II	2010-07-09
K092573	Nihon Kohden Qp-160Ak EEG Trend Program	Nihon Kohden America Inc	OMA	Class II	2010-07-09
K092306	Securacath Universal	Interrad Medical Inc	LJS	Class II	2010-07-09
K101648	Hi-Torque Winn Guide Wire Family	Abbott Vascular	DQX	Class II	2010-07-08
K101415	Theraclear	Theravant Corporation	GEX	Class II	2010-07-08
K101144	Modification To:radius Spinal System	Howmedica Osteonics Corp	NKB	Class II	2010-07-08
K101060	Siesta Medical, Inc., Prelude Tongue Suspension System	Siesta Medical, Inc.	ORY	Class II	2010-07-08
K101032	Cardo Medical Femoral Cement Restrictor, Model 503-Mcrx	Cardo Medical Corp.	JWH	Class II	2010-07-08
K100705	Zyno Z-800 Infusion System Model Z-800	Zyno Medical LLC.	FRN	Class II	2010-07-08
K100461	Pdm, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut	Riverpoint Medical, LLC	NEW	Class II	2010-07-08
K100253	Visumax Laser Keratome	Carl Zeiss Meditec Inc	HQF	Class II	2010-07-08
K100234	Hm-Lamp II	Hillusa, Inc.	FTD	Class II	2010-07-08
K100057	Powder-Free Vinyl Patient Examination Gloves, Colored (Yellow)	Tangshan Kangyuan Glove Co., Ltd.	LYZ	Class I	2010-07-08
K093801	Impella Controller	Abiomed, Inc.	KFM	Class II	2010-07-08
K100984	Xylos Vessel Guard	Xylos Corporation	OMR	Class II	2010-07-07
K101736	Non-Contact Forehead Infrared Thermometer, Model Dt-8806H, Body Infrared Thermometer, Model Dt-8806 and Digital Infrared	Shenzhen Everbest Machinery Industry Co Ltd	FLL	Class II	2010-07-06
K101195	6-Acetylmorphine Enzyme Immunoassay with 6-Acetylmorphine Calibrators and Controls	Lin-Zhi International Inc	DJG	Class II	2010-07-06
K100728	Athena Multi-Lyte Borrelia Vlse-1/Pepc10 Plus Test System	Zeus Scientific LLC	LSR	Class II	2010-07-06
K100287	Jbaids Influenza A/h5 Detection Kit, Model Jrpd-Asy-0136	U.S. Army Medical Material Development Command	NXD	Class II	2010-07-06
K100051	Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of Abuse Urine Test (Panel, Cup)	Alfa Scientific Designs, Inc.	DJG	Class II	2010-07-06
K093383	Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6, Nuclisens Easyq Analyzer, Nuclisens Minimag	bioMerieux, Inc.	OOI	Class II	2010-07-06
K091409	Lightcycler Mrsa Advanced Test for Use with the Lightcycler 2.0 Instrument, Model 05205727	Roche Molecular Systems Inc	NQX	Class II	2010-07-06
K101705	Mistral-Air Warming System	The Surgical Company International B.V.	DWJ	Class II	2010-07-02
K101667	Ensite Velocity System Referred to Ensite Velocity System with Positional Reference Tool (Prt)	Abbott Medical	DQK	Class II	2010-07-02
K101487	Cheetah Nicom System	Cheetah Medical, Inc.	DXG	Class II	2010-07-02
K101474	Md Vision System	Perkins Healthcare Technologies	DXJ	Class II	2010-07-02
K101403	Eli 250 Electrocardiograph	Mortara Instrument, Inc.	DPS	Class II	2010-07-02
K101083	Dss Stabilization System	Paradigm Spine GmbH	NQP	Class II	2010-07-02
K100979	Nitrile Exam Glove, Powder-Free Model Color White, Nitrile Exam Glove, Powder-Free Model Color Blue	Jiangsu Sunshine Plastic Products, Co., Ltd.	LZA	Class I	2010-07-02
K100620	Fully Automatic Electronic Blood Pressure Monitor , Model Kn-550	Harvard Medical Devices, Ltd.	DXN	Class II	2010-07-02
K100584	Evis Exeraii 180 System	Olympus Medical Systems Corp.	NWB	Class II	2010-07-02
K100414	Protoe Endosorb Small Hammer Toe Pin	Merete GmbH	JDW	Class II	2010-07-02
K100302	Medline PVC Urethral Catheter	MEDLINE INDUSTRIES, LP - Northfield	EZD	Class II	2010-07-02
K093473	Kmd-Mark1 Tissue Marker	Kent Medical Devices, Inc.	NEU	Class II	2010-07-02
K093189	Actiprotect Uc N95 Respirator	Glaxosmithkline Consumer Healthcare	ORW	Class II	2010-07-02
K092859	Merits Model N Series Nebulizer Compressors	Merits Health Products, Inc.	CAF	Class II	2010-07-02
K090950	Bone Plus Bcp	Megagen Implant Co., Ltd.	LYC	Class II	2010-07-02
K101711	Ceruleau Electrosurgical Probe	Nuortho Surgical, Inc.	GEI	Class II	2010-07-01
K101685	Ip-Set	Integral Process SAS	DRX	Class II	2010-07-01
K101669	Thermodilution Catheter	Biosensors Intl. Pte., Ltd.	DQO	Class II	2010-07-01
K101580	Nev's Ink Autoclave Tapes	Nev's Ink, Inc.	JOJ	Class II	2010-07-01