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 1365 of 3531

510(k) clearances, page 1365 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K041934	3M Littmann Electronic Stethoscope, Model 3000	3M Company	DQD	Class II	2004-10-15
K041918	Integrated Patient Monitoring System	Invivo Research, Inc.	MWI	Class II	2004-10-15
K041740	Silicone Coated Guidewire	Arrow International LLC (subsidiary of Teleflex Incorporated)	DQX	Class II	2004-10-15
K041718	Keles Facemask	Great Lakes Orthodontics, Ltd.	DZB	Class II	2004-10-15
K041506	Intravascular Access Introducer Sheath	Applied Medical Resources Corp	DYB	Class II	2004-10-15
K040875	Cap-One, Model Tg-920P	Nihon Kohden America Inc	CCK	Class II	2004-10-15
K040760	Modification to Ureteral Stent	Applied Medical Resources Corp	FAD	Class II	2004-10-15
K031296	Liqui-Heme Glyco A1c Assay	Biodiagnostic Intl	LCP	Class II	2004-10-15
K042667	Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024 (Seednetgold)	Galil Medical Ltd.	GEH	Class II	2004-10-14
K042590	Transderm Ionto System, Mk 2	Mattioli Engineering Corp.	EGJ	Class II	2004-10-14
K042502	3 Series Phototherapy Cabinet	The Daavlin Distributing Co.	FTC	Class II	2004-10-14
K042405	Painpump1; Painpump2	Stryker Corp.	FRN	Class II	2004-10-14
K042367	Nylon Threaded Needle	Aros Surgical Instruments Corporation	GAR	Class II	2004-10-14
K042336	Meter Trax Trilevel, Low Level, Mid Level, High Level Trilevel Minipak	Bio-Rad Laboratories Inc.	JPK	Class II	2004-10-14
K042063	Press Tack Needle	Asia-Med GmbH & Co. Kg. - Werk Suhl	MQX	Class II	2004-10-14
K041943	Xtrac Xl, Model Al8000	Photo Medex, Inc.	GEX	Class II	2004-10-14
K041662	Apnea Risk Evaluation System (Ares)	Advanced Brain Monitoring, Inc.	MNR	Class II	2004-10-14
K041628	Aeskulisa Ds DNA G	Aesku Diagnostics	LSW	Class II	2004-10-14
K041530	Excalibur Light Therapy System, Model Sgiex-04-001	Stargate International, Inc.	NHN	Class II	2004-10-14
K041525	Hemovac Blood Reinfusion System	Zimmer GmbH	CAC	Class II	2004-10-14
K041222	Pinnacle Tpn Management System Transfer Set	B.Braun Medical, Inc.	LHI	Class II	2004-10-14
K041155	Wide Range C-Reactive Protein (Wr Crp) Assay	Stanbio Laboratory	DCK	Class II	2004-10-14
K033421	Erbe Biclamp Open and Laparoscopic Instruments	Erbe USA Inc	GEI	Class II	2004-10-14
K042742	Heidelberg Retina Tomograph II / Rostock Cornea Module (Hrt II / Rcm)	Heidelberg Engineering GmbH	MXK	Class II	2004-10-13
K042736	Cdx Digital X-Ray Imaging System	Cnc Imaging, Inc.	MUH	Class II	2004-10-13
K042655	Inspiration Elite Nebulizer Compressor, with Nebulizer, Model Hs456	Respironics New Jersey, Inc.	CAF	Class II	2004-10-13
K042581	Amluck, Ya Horng	Ya Horng Electronic Co., Ltd.	DXN	Class II	2004-10-13
K042271	Nexgen Complete Knee Solution Lps-Flex Prolong Highly Crosslinked Polyethylene Articular Surfaces	Zimmer GmbH	JWH	Class II	2004-10-13
K041110	Mb 105 Millennium Blades	Millennium Biomedical, Inc.	HNO	Class I	2004-10-13
K040783	Foundation	Terumo Corp.	LYC	Class II	2004-10-13
K042703	Cybird LED Curing Light	Dxm Co., Ltd.	EBZ	Class II	2004-10-12
K042616	Biomedix Padnet Lab	Biomedix Wai	JOM	Class II	2004-10-12
K042561	Twinheads Th-103 Extracorporeal Shock Wave Lithotripter	Fmd, LLC	LNS	Class II	2004-10-12
K042541	Modification to Polarcath Peripheral Dilatation System	Cryo Vascular Systems, Inc.	DQY	Class II	2004-10-12
K042501	Etg-4000 Optical Topography System	Hitachi Medical Corp.	DQA	Class II	2004-10-12
K042173	Coulter a T 5Diff Cap Pierce (Cp)	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2004-10-12
K031728	Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg Warmer Thermal Blanket	Klimamed Technologie Medizingerate GmbH	DWJ	Class II	2004-10-12
DEN040007	Verichip Health Information Microtransponder and Pocket Reader	Digital Angel Corporation	NRV	Class II	2004-10-12
K042764	Medline Strider Midi 4	MEDLINE INDUSTRIES, LP - Northfield	INI	Class II	2004-10-08
K042634	Wide 1Mp Lcd Monitor System	Wide Corporation	LLZ	Class II	2004-10-08
K042605	Colongraphy Software Package with Extended Functionality	Siemens AG Medical Solutions	NWE	Class II	2004-10-08
K042554	Auto Therm 390, Model Me 390	Mettler Electronics Corp	IMJ	Class II	2004-10-08
K042524	Modification to Vertex Reconstruction System	Medtronic Sofamor Danek	KWP	Class II	2004-10-08
K042517	Biosorb Fx and Biosorb Pdx 1.5 and 2.0 Screws	Linvatec Biomaterials, Ltd.	JEY	Class II	2004-10-08
K042437	Dorsal Intramedullary Plate	Deo Volente Orthopaedics, LLC	HRS	Class II	2004-10-08
K042419	Fabius Gs/fabius Tiro Anesthesia System	Draeger, Inc.	BSZ	Class II	2004-10-08
K042416	Athena Multi-Lyte Ana-II Test System	Zeus Scientific LLC	LKJ	Class II	2004-10-08
K042410	Baxject II	Baxter Healthcare Corporation	LHI	Class II	2004-10-08
K042408	Iqqa-Chest Software Package	Edda Technology, Inc.	OMJ	Class II	2004-10-08
K042403	Mirage Swift	ResMed Corp	BZD	Class II	2004-10-08