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 1351 of 3531

510(k) clearances, page 1351 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042705	Disposable Non-Adhesive Spo2 Sensors	Elekon Industries U.S.A., Inc.	DQA	Class II	2004-12-29
K042414	Visioplast Acrylic Resin	Tecres SpA	GXP	Class II	2004-12-29
K041652	Acupuncture Needles	C.A.I. Industries Corp.	MQX	Class II	2004-12-29
K041407	Titanium Mesh Implant	Interpore Cross Intl.	MQP	Class II	2004-12-29
K030526	Pediguard Nerve Detector System	Spine Vision, Inc.	GWF	Class II	2004-12-29
K043403	Cemex System Genta Fast Bone Cement	Exactech, Inc.	LOD	Class II	2004-12-28
K043343	Modification to: Cd Horizon Spinal System	Medtronic Sofamor Danek	MNH	Class II	2004-12-28
K042930	Spacevision Cage System	Spine Vision, Inc.	MQP	Class II	2004-12-28
K042478	Capsule Tension Ring Inserter, Model 7-810	Duckworth & Kent, Ltd.	NCE	Class I	2004-12-28
K042381	Coronary Sinus Visualization System, Model Csvs5508	Acumen Medical, Inc.	DQY	Class II	2004-12-28
K043404	Modification to T2 Proximal Humeral Nail	Howmedica Osteonics Corp	HSB	Class II	2004-12-27
K042947	Parallax Acrylic Resin with Tracers, Model Kp-Par-003	ArthroCare Corporation	NDN	Class II	2004-12-27
K042911	Cementek Lv	Teknimed SAS	MQV	Class II	2004-12-27
K042902	Herbert Ulnar Head Prosthesis System	Stuckenbrock Medizintechnik GmbH	KXE	Class II	2004-12-27
K042362	Modification to Carbon Dioxide-L3k Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and 299-12	Sekisui Diagnostics P.E.I. Inc.	KHS	Class II	2004-12-27
K042329	Salicylate-Sl Assay	Sekisui Diagnostics P.E.I. Inc.	DKJ	Class II	2004-12-27
K042288	Unicryl	United Medical Industries Co. Ltd.	GAM	Class II	2004-12-27
K040977	Genchem Electrolyte Buffer	Genchem, Inc.	JGS	Class II	2004-12-27
K040976	Genchem Creatinine Reagent	Genchem, Inc.	CGX	Class II	2004-12-27
K040975	Genchem CO2 Acid Reagent	Genchem, Inc.	JFL	Class II	2004-12-27
K040974	Glucose Oxidase, Glucose	Genchem, Inc.	CGA	Class II	2004-12-27
K040973	Bun Reagent	Genchem, Inc.	CDS	Class II	2004-12-27
K040972	Calcium, Azo Dye Reagent	Genchem, Inc.	CJY	Class II	2004-12-27
K032434	Clinical Electronic Thermometer	Cotronic Manufacturing	FLL	Class II	2004-12-27
K043381	Infinia Lightspeed	GE Medical Systems F.I. Haifa	KPS	Class II	2004-12-23
K043318	Modification to Roche Elecsys Folate II Immunoassay	Roche Diagnostics GmbH	CGN	Class II	2004-12-23
K043276	Datex-Ohmeda S/5tm Fm with L-Ficu04 and L-Ficu04a Software and N-Fcrec Module	GE Healthcare	MHX	Class II	2004-12-23
K043241	Lofric Hydro-Kit II Single Use Urinary Catheter	Astra Tech, Inc.	GBM	Class II	2004-12-23
K043237	Vitek Gram Negative Susceptibility (Gns) Card for Moxifloxacin	bioMerieux, Inc.	LON	Class II	2004-12-23
K043202	Olympus Creatine Kinase Reagent Osr6179/osr6279	OLYMPUS Corporation of the Americas	CGS	Class II	2004-12-23
K043090	Easylistener 2 Fm, Radium Fm and Vocalight Infrared Sound Field Systems	Phonic Ear, Inc.	LZI	Class II	2004-12-23
K043086	Somatom Respiratory Gating	Siemens Medical Solutions USA, Inc.	JAK	Class II	2004-12-23
K042985	Lifestent Nt35 Biliary Stent System	Edwards Lifesciences LLC	FGE	Class II	2004-12-23
K042620	Sonata 3-D Imaging Accessory, Model 3Ds	Tetrad Corp.	IYO	Class II	2004-12-23
K042038	Mtf Allograft Anchor	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	GAT	Class II	2004-12-23
K041757	Femspec Disposable Vaginal Speculum	Femspec LLC	HIB	Class II	2004-12-23
K041078	Surgplan and Panplan	Dental Imaging Technologies Corporation	LLZ	Class II	2004-12-23
K040778	Tanita Innerscan Body Composition Monitor, Model Bc-53X (Where X=0 to 9)	Tanita Corp. of America	MNW	Class II	2004-12-23
K030295	Ltu-904 Portable Laser Therapy Unit	Riancorp Pty Ltd	NZY	Class II	2004-12-23
DEN040012	Affymetrix Genechip Microarray Instrumentation System	Affymetrix Inc	NSU	Class II	2004-12-23
DEN040011	Amplichip Cyp450 Test, Model 04381866190	Roche Molecular Systems Inc	NTI	Class II	2004-12-23
K043311	Ascensia Elite Diabetes Care System	Medrad, Inc.	NBW	Class II	2004-12-22
K043272	Pallindrome 14.5Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip	Kendall	MSD	Class II	2004-12-22
K043269	Lysus Infusion System	Ekos Corp.	QEY	Class II	2004-12-22
K043247	Ducera Allceram	Dentsply Intl.	EIH	Class II	2004-12-22
K043239	Healthstar Elite	Hill Laboratories	ITH	Class II	2004-12-22
K043184	Hemosil Recombiplastin	Instrumentation Laboratory Co.	GJS	Class II	2004-12-22
K043158	Ascensia Brio Blood Glucose Monitoring System	Medrad, Inc.	NBW	Class II	2004-12-22
K043081	Gore Polypropylene Hernia Mesh	W. L. Gore & Associates, Inc.	FTL	Class II	2004-12-22
K043076	Ge Oec Fluorostar	GE Healthcare	OWB	Class II	2004-12-22