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 1580 of 3531

510(k) clearances, page 1580 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K011049	Expresssuite	Vidar Systems Corp.	LMA	Class II	2001-10-01
K003322	Codman Bactiseal Catheters	Cerenovus, Inc.	HCA	Class II	2001-10-01
K003238	Solid State X-Ray Imaging Devices	Cares Built, Inc.	MQB	Class II	2001-10-01
K990323	Te Me Na Polystim Nerve Stimilator	Te ME NA S.A.R.L.	BXN	Class II	2001-09-28
K013138	Adc Compact Plus	AGFA Healthcare Corp.	MQB	Class II	2001-09-28
K013080	Reaads Anti-Beta 2 Glycoprotein I Igg Test Kit	Corgenix, Inc.	MSV	Class II	2001-09-28
K013079	Reaads Anti-Beta 2 Glycoprotein I Iga Test Kit	Corgenix, Inc.	MSV	Class II	2001-09-28
K013077	Reaads Anti-Beta 2 Glycoprotein I Igm Test Kit	Corgenix, Inc.	MSV	Class II	2001-09-28
K012939	Aerovent II Chc Collapsible Holding Chamber	Monaghan Medical Corp.	CAF	Class II	2001-09-28
K012934	Cell-Dyn 3200 System with Absolute and Percent Reticulocyte	Abbott Medical	GKZ	Class II	2001-09-28
K012926	Modification to Ensite 3000 System, Model Ee3000	Endocardial Solutions, Inc.	MTD	Class II	2001-09-28
K012913	Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter	C.R. Bard Inc	DQY	Class II	2001-09-28
K012911	3I Locater Abutment System	ZimVie US Corp LLC	DZE	Class II	2001-09-28
K012907	Liquispx Liquid Saliva or Unrine Drug of Abuse Control	Clinical Controls, Inc.	DIF	Class I	2001-09-28
K012797	Diamedix Is-Anti-Gliadin Iga Test System	Diamedix Corp.	MST	Class II	2001-09-28
K012795	Diamedix Is-Anti-Gliadin Igg Test System	Diamedix Corp.	MST	Class II	2001-09-28
K012723	Plateletworks	Helena Laboratories, Corp.	JOZ	Class II	2001-09-28
K012470	Modification to N Protein Standard Sl	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2001-09-28
K012428	Modification to: Lifepak 500 Automated External Defibrillator	Physio Control, Inc.	MKJ	Class III	2001-09-28
K012372	Sysmex Uf-50	Sysmex Corporation	LKM	Class II	2001-09-28
K012290	Rapidia	3D Med Co., Ltd.	LLZ	Class II	2001-09-28
K012270	Stryker Cross-Pinned Interference Screw System	Stryker Corp.	JDW	Class II	2001-09-28
K012173	Device Modification of Silhouette Spindal Fixation System	Zimmer Spine, Inc.	KWP	Class II	2001-09-28
K012114	Synthes Locking Distal Radius Plating System	Synthes (USA) Products LLC	HRS	Class II	2001-09-28
K011574	Uniplant Dental Implant System	Universal Implant Systems, Inc.	DZE	Class II	2001-09-28
K011568	Randox Lipoprotein	Randox Laboratories, Limited	JIS	Class II	2001-09-28
K010949	2010 Plus Holter for Windows	Agilent Technologies, Inc.	MLO	Class II	2001-09-28
K010913	Vygon Split Cannula Introducer	Vygon Corp.	DYB	Class II	2001-09-28
K010882	Blue Sky Bio Dental Implant System	Blue Sky Bio, LLC	DZE	Class II	2001-09-28
K010749	Electro Neuromuscular Stimulator, Model Nms-Digital	BioMedical Life Systems Inc.	IPF	Class II	2001-09-28
K010619	Ucla and Universal Abutments	Diamodent	DZE	Class II	2001-09-28
K010592	Aqua Water Treatment for Hemodialysis	Aqua Water Treatment, Inc.	FIP	Class II	2001-09-28
K010467	Universal Dental Coping (Udc)	Paxmed International, LLC	DZE	Class II	2001-09-28
K003780	Vertex Reconstruction System	Medtronic Sofamor Danek	KWP	Class II	2001-09-28
K003191	Mis Implant System Decive	MIS Implants Technologies Ltd.	DZE	Class II	2001-09-28
K000035	Omnicare Dental Implant System	Omnicare Dental Implant Center	DZE	Class II	2001-09-28
K013084	Affinity 38 Micon Arterial Filter with Trillium Biopassive Surface, Model 351T	Medtronic Perfusion Systems	DTM	Class II	2001-09-27
K012901	Color-Monogen	Instrumentation Laboratory Co.	KTN	Class II	2001-09-27
K012202	Numaris 4Va15a	Siemens Medical Corp.	LNH	Class II	2001-09-27
K012160	Compcore Af Composite Core Build-Up Material, Model 3001408	Premier Dental Products Co	EBF	Class II	2001-09-27
K012078	Radiofix	Fixano SA	KTT	Class II	2001-09-27
K012062	Pf2	Fixano SA	KTT	Class II	2001-09-27
K011800	Vanguard Reprocessed Electric Biopsy Forceps	Stryker Sustainability Solutions	NLU	Class II	2001-09-27
K011405	Exel Injection Plug with Cap	Exelint Intl. Co.	FPA	Class II	2001-09-27
K010732	Vitallink 1200 Mobile Vital Signs Systems (Vl 1200 System)	Telemedic Systems, Inc.	MWI	Class II	2001-09-27
K010712	Dialysate Line with Connectors/re-Use Wash-Out Lines	Molded Products Inc	FID	Class II	2001-09-27
K010478	Dideco D901 Lilliput Hollow Fiber Oxygenator with or without Soft Venous Reservoir Bag, with Biocompatable Treatment Sur	Dideco S.p.A.	DTZ	Class II	2001-09-27
K010335	Slendertone Flex, Model, 512	Bio-Medical Research, Ltd.	NGX	Class II	2001-09-27
K012866	The Nexgen Tmt Tibia, Models 00-5886-Xxyy, 05-120-Xxyy-0	Implex Corp.	JWH	Class II	2001-09-26
K012540	Bly-501 Adaptor	Micromedical Industries, Ltd.	DPS	Class II	2001-09-26