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 2026-11-05, 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 1355 of 3531

510(k) clearances, page 1355 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K043070	Liquid Stable Hba1c Control	Canterbury Scientific Ltd.	JJX	Class I	2004-12-09
K043041	Aesculap T-Bar Aneurysm Clips (Titanium & Phynox)	Aesculap Inc	HCH	Class II	2004-12-09
K043030	Magnetom C! Mr System	Siemens Medical Solutions	LNH	Class II	2004-12-09
K042838	Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry Products Palb Performance Verifiers I & II	Ortho-Clinical Diagnostics, Inc.	JIT	Class II	2004-12-09
K042689	Nichols Advantage Cortisol	Nichols Institute Diagnostics	CGR	Class II	2004-12-09
K042588	Confluent Surgical Dual Liquid Applicator, Model 70-2005093	Confluent Surgical,Inc	FMF	Class II	2004-12-09
K042454	Stryker Cassette Pump	Stryker Corp.	GCX	Class II	2004-12-09
K042413	Acs Model Ncp-2	Applied Cardiac Systems	DRN	Class II	2004-12-09
K042318	Audit Microcv General Chemistry Linearity Set	Aalto Scientific Ltd.	JJY	Class I	2004-12-09
K041477	Pathfinder	Armstrong Healthcare Limited	HAW	Class II	2004-12-09
K043140	Express and Oasis Chest Drain	Atrium Medical Corporation	CAC	Class II	2004-12-08
K043079	Bicontact Hip System with U-Cap	Aesculap Inc	MEH	Class II	2004-12-08
K042931	Tuf Link Silicone Reliner	Dentatus USA Ltd.	EBI	Class II	2004-12-08
K042664	Lps Upper Extremity	Depuy, Inc.	JDC	Class II	2004-12-08
K042629	Varelisa Sm Antibodies, Model 18296	Sweden Diagnostics (Germany) GmbH	LKP	Class II	2004-12-08
K042574	Esteem Blue Polyisoprene Surgical Gloves with Coating (Containing Chitosan, Provitamin B, Gluconolactone and Glycerol)	Cardinalhealth	KGO	Class I	2004-12-08
K041294	Biozdx Hemodynamic Monitor	Cardiodynamics International Corp.	DSB	Class II	2004-12-08
K043193	Bard Inlayoptima Ureteral Stent with Suture	C.R. Bard Inc	FAD	Class II	2004-12-07
K043108	Liquichek Specialty Immunoassay Control	Bio-Rad Laboratories Inc.	JJY	Class I	2004-12-07
K042970	Copan Universal Transport Medium (Utm-Rt) System	COPAN Diagnostics, Inc.	JSM	Class I	2004-12-07
K042946	Vitek Gram Positive Susceptibility (Gps) Card for Rifampin	bioMerieux, Inc.	LON	Class II	2004-12-07
K042723	Trigage Profiler S.o.b. Panel, Model 97300	Biosite Incorporated	DAP	Class II	2004-12-07
K042452	Riva Silver	Southern Dental Industries, Inc.	EMA	Class II	2004-12-07
K042322	Sterichek Blood Leak Reagent Strips	Hach Company	FJD	Class II	2004-12-07
K033260	Aequos	AAP Implantate AG	JWH	Class II	2004-12-07
K043256	Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System Sterile Empy Vials, Model 6021-04-03	Abbott Medical	MEA	Class II	2004-12-06
K043186	H & L (Nibp) Blood Pressure Monitor, Model Hl888em	Health & Life Corporation	DXN	Class II	2004-12-06
K042929	Estenia C&b	Kuraray Medical Kurashiki Plant	EBF	Class II	2004-12-06
K042817	Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use)	Ansell Healthcare Products LLC	LZA	Class I	2004-12-06
K042675	Flexi-Stat Sp02 Ear Sensor	Elekon Industries U.S.A., Inc.	DPZ	Class II	2004-12-06
K042252	Nexflex Total Hip System	Alphatec/Nexmed	LPH	Class II	2004-12-06
K040865	Aesculap Sterrad 100S Compatable Sterilcontainer	Aesculap Inc	FRG	Class II	2004-12-06
K030052	Ostim	Kulzer GmbH	LYC	Class II	2004-12-06
K043080	Heparin Dose Response Controls, Model 306-20 Por	Medtronic, Inc.	JOX	Class II	2004-12-03
K043069	Hoveround E100 Power Chair	Hoveround Corp.	ITI	Class II	2004-12-03
K043023	Pruitt-Inahara Outlying Carotid Shunt, Models, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49	LeMaitre Vascular Inc.	MJN	Class II	2004-12-03
K042967	A&d Medical Lifesource Digital Blood Pressure Monitors, Models Ub-511 & Ub-512	A and D Engineering, Inc.	DXN	Class II	2004-12-03
K042920	Hoveround Se-3 Powerchair	Hoveround Corp.	ITI	Class II	2004-12-03
K042862	Bd Onecath	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	2004-12-03
K042860	Correct Dental Impression Material	Handae Chemical Co., Ltd	ELW	Class II	2004-12-03
K042858	55Cm 15.5Fr Decathlon Twin Lumen Hemodialysis Catheter W/separated Tips	Spire Biomedical, Inc.	MSD	Class II	2004-12-03
K042856	Contour Forehead/browlift Thread	Surgical Specialties Corp	GAW	Class II	2004-12-03
K042840	Shimadzu Collimator R-20J	Shimadzu Corp.	IZX	Class II	2004-12-03
K042548	Cerasys - Zr	Cerasys, Inc.	EIH	Class II	2004-12-03
K042427	Genestone Exel (Xl) Extracorporeal Shock Wave Lithotripter	Genemed, Inc.	LNS	Class II	2004-12-03
K042406	Olympus Lactate, Osr6193	OLYMPUS Corporation of the Americas	JIT	Class II	2004-12-03
K042284	Unimide	United Medical Industries Co. Ltd.	GAR	Class II	2004-12-03
K042148	Heart Rate Turbulence Analysis Technologies	GE Medical Syst. Information Technologies	DQK	Class II	2004-12-03
K041834	Adr Plus Ssxi Imaging Device for X-Ray Systems Such as X-Caliber, X-Caliber Cm, Ana-Bel and Ana-Bel Cm	Takara Belmont USA, Inc.	MUH	Class II	2004-12-03
K043027	Monarch, Transshaping Gastrostomy Tube, Model 9-Xx20	Applied Medical Technology Inc	KNT	Class II	2004-12-02