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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1727 of 3533

510(k) clearances, page 1727 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K991966	The Nomos Chane II	Nomos Corp.	IYE	Class II	1999-09-03
K991946	Ultra-Kleen Powder for Dental Unit Water Lines, Models 513P, 505L	Sterilex Corp.	EIA	Class I	1999-09-03
K991915	Modular Radial Head	Wrightmedicaltechnologyinc	KWI	Class II	1999-09-03
K991910	Lifepak 12 Biphasic	Physio Control, Inc.	MKJ	Class III	1999-09-03
K991274	Mumps Igg Elisa Test System	Columbia Bioscience, Inc.	LJY	Class I	1999-09-03
K991185	Borrelia Burgdorferi Igm Western Blot Test System	Zeus Scientific LLC	LSR	Class II	1999-09-03
K991180	Borrelia Burgdorferi Igg Western Blot Test System	Zeus Scientific LLC	LSR	Class II	1999-09-03
K991159	Prismatherm II, Astoline	Stihler Electronic GmbH	BSB	Class II	1999-09-03
K990979	Steco-Titanmagnetics	Steco-System-Technik GmbH & Cokg	EGG	Class I	1999-09-03
K990762	Zoll M Series with Rectilinear Bi-Phasic Option (M Series Bi-Phasic)	ZOLL Medical Corporation	MKJ	Class III	1999-09-03
K990689	Zynergy Lock-Sure Single Pass Drainage Catheter, Z10005/7/9	Zcv,Inc.	LJE	Unclassified	1999-09-03
K990494	Modification of Noga	Biosense, Ltd.	DQK	Class II	1999-09-03
K990462	Is H. Pylori Igg Elisa Test System	Columbia Bioscience, Inc.	LYR	Class I	1999-09-03
K990148	Stackable Cage System	Depuy Motech Acromed	MQP	Class II	1999-09-03
K984391	The Liberator	Liberator Wheelchairs, Inc.	IPL	Class II	1999-09-03
K984101	Flexiblade	Arco Medic, Ltd.	CCW	Class I	1999-09-03
K982926	Fresenius Blood Volume Monitor	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	1999-09-03
K980024	Shinmed Model Sw-966 Ultrasonic Nebulizer	Shining World Health Care Co., Ltd.	CAF	Class II	1999-09-03
K992748	Drugcheck X Multidrug Screening Device	Syntron Bioresearch, Inc.	DIO	Class II	1999-09-02
K992172	Lyphochek Tumor Marker Control, Model 580	Bio-Rad	JJY	Class I	1999-09-02
K991948	Dr. B's Mouthpiece, Model 32129-10002	Snore - Ezzer	LRK	Class II	1999-09-02
K991923	Soothe-N-Seal Canker Sore Relief	Closure Medical Corp.	MZW	Class II	1999-09-02
K991762	Alkaline Phophatase (Alp), Product No's 118-01, 118-02	A.P. Total Care, Inc.	CJE	Class II	1999-09-02
K991761	Magnesium Product No's, 112-01, 112-02	A.P. Total Care, Inc.	JGJ	Class I	1999-09-02
K991160	Astotherm Plus, Astotubes, Astoline	Stihler Electronic GmbH	BSB	Class II	1999-09-02
K991112	Sage Contrast Management System	Sage Laboratories, Inc.	FPA	Class II	1999-09-02
K990867	Rx Herculink 14 Biliary Stent System, Model 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18	Advanced Cardiovascular Systems, Inc.	FGE	Class II	1999-09-02
K992818	Optimax/ Compact 2	Protec GmbH & Co. KG	IXW	Class II	1999-09-01
K992808	A&d Medical Tm-2430 and Tm-2431 Ambulatory Blood Pressure	A&D Medical Div.	DXN	Class II	1999-09-01
K992773	Ceralas D10 810Nm Diode Laser	Ceram Optec, Inc.	GEX	Class II	1999-09-01
K992761	Sonoace 5500 Diagnostic Ultrasound System	Medison America, Inc.	IYO	Class II	1999-09-01
K992570	Unitrax C-Taper Neck Adjustment Sleeve	Howmedica Osteonics Corp	KWL	Class II	1999-09-01
K992545	Tm-300 Traction System	Ito Co., Ltd.	ITH	Class II	1999-09-01
K992535	Endius Suction/irrigation Instrument	Endius, Inc.	OCX	Class II	1999-09-01
K992301	Reunite Screws	Biomet Manufacturing Corp	HWC	Class II	1999-09-01
K992190	Core Pouch	Core Dynamics, Inc.	GCJ	Class II	1999-09-01
K992103	C-Quest	Wuestec Medical, Inc.	OWB	Class II	1999-09-01
K992078	Vantage Exspect II	Philips North America LLC	KPS	Class II	1999-09-01
K991963	Patton Speculum	Patton Medical Corp.	HIB	Class II	1999-09-01
K991922	Digital Imaging System (Bsr)	Siemens Medical Solutions USA, Inc.	IZI	Class II	1999-09-01
K991905	Corometrics Model 171 and 172 Fetal Monitor	General Electric Medical Systems Information Techn	HGM	Class II	1999-09-01
K991899	Nihon Kohden Meb-2200A Neuropack Evoked Potential & EMG Measuring System with Accessories	Nihon Kohden America Inc	GWF	Class II	1999-09-01
K990873	Dbest Urinary Tract Infection Test Kit for Home-Use	Ameritek, Inc.	JMT	Class I	1999-09-01
K990592	Intrastent II	Intratherapeutics, Inc.	FGE	Class II	1999-09-01
K990412	Cuff-Able Plus	Vital Signs, Inc.	DXQ	Class II	1999-09-01
K990338	Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/monitor System	Physio Control, Inc.	DXN	Class II	1999-09-01
K974387	Pdm3 Disinfection System for Peritoneal Dialysis Exchanges, Patient Transfer Set Pts102, Cap, High Temperature	Microwave Medical Systems, Inc.	KDJ	Class II	1999-09-01
K992636	Hp Carevue 9000 Clinical Information System, Model M2331a	Hewlett-Packard Co.	DXJ	Class II	1999-08-31
K992569	Medtronic Ave Bridge Stent	Medtronic, Inc.	FGE	Class II	1999-08-31
K992102	Luma Light 2000 Cure Light	Lumalite, Inc.	EBF	Class II	1999-08-31