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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3000 of 3529

510(k) clearances, page 3000 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K850881	Alba Dry Burn Pad	Alba Health Care			1985-04-17
K850560	Flowmeter, Backpressure Compensated, Thorpe Tube	Precision Medical, Inc.	CAX	Class I	1985-04-17
K850360	Eschweiler System 2000 - Glood Gas Analyzers	Text Tech Corp.	CHL	Class II	1985-04-17
K850273	Ethicon - Cholangioclip	Ethicon, Inc	FZP	Class II	1985-04-17
K844080	Arrow-Geiss Percutaneous Tpn Kit	Arrow Intl., Inc.	LJS	Class II	1985-04-17
K843013	H-H Tendeon Implant	Holter-Hausner Intl.			1985-04-17
K840113	Silicone Splinting Material	General Dental Products, Inc.	MDA	Class I	1985-04-17
K851091	Medtronic Model 5328 Program-Stimulator	Medtronic, Inc.	JOQ	Class II	1985-04-16
K850988	Bovo Moisture Guard	E.H. Medical Co.	KHR	Class I	1985-04-16
K850915	Wax Bite Impression Wafer	Toothprints, Inc.	EGD	Class I	1985-04-16
K850911	Triad C & B Material	Dentsply Intl.	EBF	Class II	1985-04-16
K850863	Ultrafil-Lt (Gutta Percha)	The Hygenic Company, LLC	EKM	Class I	1985-04-16
K850317	Unisonic Electronic Digital Bp Monitor Ebm-3050	Nihon Seimitsu Sokki Co., Ltd.	DXN	Class II	1985-04-16
K850316	Unisonic Electronic Digital Bp Monitor Ebm-2050	Nihon Seimitsu Sokki Co., Ltd.	DXN	Class II	1985-04-16
K850315	Unisonic Electronic Digital Bp Monitor Ebm-1050	Nihon Seimitsu Sokki Co., Ltd.	DXN	Class II	1985-04-16
K850173	Ausonics-Alpha I Diagnostic X-Ray Mammography Unit	Ausonics Pty, Ltd.	IZH	Class II	1985-04-16
K850172	Elekiban Magneto-Therapeutic Device	Mns, Ltd.			1985-04-16
K850087	Biological Telemetry System	Chattanooga Group, Inc.			1985-04-16
K844926	Head-Spine Stabilizer Hss-1	Imaging Accessories, Inc.	JAK	Class II	1985-04-16
K844766	Nd1100 Bone Density Scanner	Nuclear Data, Inc.	KGI	Class II	1985-04-16
K843708	Adac Dps-4070 Digital Radiography Sys	Philips North America LLC	LLZ	Class II	1985-04-16
K851194	Ambu CPAP System	Ambu, Inc.	BYE	Class II	1985-04-15
K851162	Al Askari Percutaneous Access Needle Holder	Van-Tec, Inc.	KOA	Class I	1985-04-15
K851158	Van-Tec Meatal Dilator	Van-Tec, Inc.	KOE	Class II	1985-04-15
K850758	Amniglove & Amnicot	Go Medical Industries Pty., Ltd.	HGE	Class I	1985-04-15
K850532	Atlantic Optical Systems, Inc. Universal Pack	Atlantic Optical Systems, Inc.	HQC	Class II	1985-04-15
K850478	Plus 1	Dymax Corp	IYO	Class II	1985-04-15
K850275	Kcp Pak #2 Convenience Pack Modification	CooperVision, Inc.	HQC	Class II	1985-04-15
K850268	Sparco Scope Guard	Sparco, Inc.	FEB	Class II	1985-04-15
K850149	Kcp (Kelman Compact Phaco-Emulsifier) Pea	CooperVision, Inc.	HQC	Class II	1985-04-15
K850148	Kcp Pak Convenience Pack	CooperVision, Inc.	HQC	Class II	1985-04-15
K850076	Wound Dressing Model Zb-6	Thermedics, Inc.	NAD	Class I	1985-04-15
K850046	Professional Supplies, Inc.lens Carrying Case	Professional Supplies, Inc.	HPX	Unclassified	1985-04-15
K843942	Henning Meniscal Suture Kit	Stryker Corp.	LXH	Class I	1985-04-15
K851379	Healthcheck Digital Thermometer Model 1 Th-2	Healthcheck Corp.	FLL	Class II	1985-04-12
K851356	Playtex Super Tampons & Super Deodorant Tampons	Intl. Playtex, Inc.	HEB	Class II	1985-04-12
K851355	Playtex Super Plus Tampons & Deodorant Tampons	Intl. Playtex, Inc.	HEB	Class II	1985-04-12
K851188	Packets for Prep. of Dialysates & Infusates -	bioMerieux, Inc.	FKT	Class II	1985-04-12
K851101	Bionomy's Multi-Lumen Central Venous Catheter-Set	Bionomy, Inc.	FOZ	Class II	1985-04-12
K851090	Monoject Sterile 1/2 Cc & 1Cc Syringes W & W/o Nee	Sherwood Medical Co.	FMF	Class II	1985-04-12
K851089	Monoject Sterile 12Cc Syringes, W/wo Needles	Sherwood Medical Co.	FMF	Class II	1985-04-12
K851071	Pharmacia Insulin Ria	Pharmacia, Inc.	CFP	Class I	1985-04-12
K851061	Emit Qst Procainamide Assay	Syva Co.	LAR	Class II	1985-04-12
K850990	Hff Gencells	Bioassay Systems Research Corp.	KIT	Class I	1985-04-12
K850949	Medix Visual Urine Hcg (7/7) Test	Medix Biotech, Inc.	JHI	Class II	1985-04-12
K850906	Tactile Plus Dental Elevators	Ipco Corp.	EMJ	Class I	1985-04-12
K850786	Total Hige Enzyme Immunoassay	Nms Pharmaceuticals, Inc.	DGC	Class II	1985-04-12
K850574	Dade Immu-Trace Tri-Rac R Tri-Level Immunoassay Co	American Dade	JJY	Class I	1985-04-12
K850392	Intelligent Photometers Mcp, Ifp, Isp, Fps, Sps	Clinical Data, Inc.	JJQ	Class I	1985-04-12
K850296	Laser RF Test -Rheumatoid Factor(s) Reagents	Behring Diagnostics, Inc.	DHR	Class II	1985-04-12