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 2273 of 3531

510(k) clearances, page 2273 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931885	Drigel Multifunction Electrode	Physiometrix, Inc.	GEI	Class II	1993-09-09
K931876	Fisk Arm Support	Vvortex International Corp.	FWW	Class I	1993-09-09
K931867	Ultra-Etch Enamel Preparation Product Line	Ultradent Products Inc.	EBF	Class II	1993-09-09
K931482	Stryker Mps Acute Care Bed	Stryker Corp.	FNL	Class II	1993-09-09
K930006	Autobead Tsh Enzyme Immunoassay Reagent Kit	Bio-Chem Laboratory Systems, Inc.	JLW	Class II	1993-09-09
K926565	Gore-Tex(tm) Dual Mesh	W. L. Gore & Associates, Inc.	FTL	Class II	1993-09-09
K926512	Storz Modified Phaco Needle with Insulation Sleeve	Storz	HQC	Class II	1993-09-09
K926318	Patient Examination Gloves	I Ching Ent., Inc.	LYY	Class I	1993-09-09
K925641	Zeiss 20 Sl Slit-Lamp & Mechanical Micromanipulatr	Carl Zeiss, Inc.	HJO	Class II	1993-09-09
K924606	Bremer Imaging Tongs-MRI Model	Bremer Medical, Inc.	HAX	Class II	1993-09-09
K921103	Retraction Instrument	Origin Medsystems, Inc.	GCJ	Class II	1993-09-09
K915547	Sarns 8000 Delphin II Centri Pump Mod W/integr Bat	3M Health Care, Sarns	KFM	Class II	1993-09-09
K933675	Opus Total Ck	Pb Diagnostic Systems, Inc.	CGS	Class II	1993-09-08
K933314	Radias Ferritin Enzyme Immunoassay	Bio-Rad	DEW	Class II	1993-09-08
K933066	Opus Estradiol	Pb Diagnostic Systems, Inc.	CHP	Class I	1993-09-08
K932871	Uibc for Discreet Random Access Analyzer	Catachem, Inc.	CFM	Class I	1993-09-08
K932688	Eye Spot Im Test	J.S. Medical Assoc.	KTN	Class II	1993-09-08
K932161	Urea Nitrogen Test Item Number 65408	Em Diagnostic Systems, Inc.	CDQ	Class II	1993-09-08
K931986	Amp Alkaline Phosphatase Reagent Kit	Synermed, Inc.	CJE	Class II	1993-09-08
K931958	Synermed Ggt Reagent Kit	Synermed, Inc.	JQB	Class I	1993-09-08
K931835	Olympus Reply Inorganic Phosphorous Reagent	Olympus Corp.	CEO	Class I	1993-09-08
K931600	Chemiluminescence Free T3 Immunoassay	Nichols Institute	CDP	Class II	1993-09-08
K931543	Encore Ena Combined Eia	Trinity Biotech USA	LLL	Class II	1993-09-08
K930979	Accu-Chek Advantage Blood Glucose System	Boehringer Mannheim Corp.	CGA	Class II	1993-09-08
K926360	Glucofilm Test Strips	Kulzer GmbH	CGA	Class II	1993-09-08
K933850	Philips 45 Series	Philips Hearing Instruments Co.	ESD	Class I	1993-09-07
K933240	Polydoros Is	Siemens Medical Solutions USA, Inc.	IZO	Class I	1993-09-07
K933145	Fiberoptic Lightsources and Carriers	Electro Fiberoptics Corp.	EQH	Class I	1993-09-07
K932977	Cabot Medical Optima Hand Instruments	Cabot Medical Corp.	GCJ	Class II	1993-09-07
K932976	Cabot Medical Optima Hand Instruments	Cabot Medical Corp.	GCJ	Class II	1993-09-07
K932720	Hm-0970	Hill-Med, Inc.	HRM	Class I	1993-09-07
K932445	Sireskop Cx	Siemens Medical Solutions USA, Inc.	JAA	Class II	1993-09-07
K932375	Mag Res Diag Dev Access Cir Pol(cp) Body/spine Coi	Siemens Medical Solutions USA, Inc.	LNH	Class II	1993-09-07
K932374	Mag Reson Diag Devi Access Cir Polar(cp) Head Coil	Siemens Medical Solutions USA, Inc.	LNH	Class II	1993-09-07
K932153	Thyroid Uptake System & Atomlab 950 Med. Spectrome	Biodan Medical Systems, Ltd.	IZD	Class I	1993-09-07
K931930	Poydoros Lx	Siemens Medical Solutions USA, Inc.	IZO	Class I	1993-09-07
K931895	Endoscope Accessory	Applied Medical Resources Corp	GCJ	Class II	1993-09-07
K931886	Tissue Isolation and Retrieval Bag	Advanced Surgical, Inc.	KGX	Class I	1993-09-07
K931537	A&e Medical Electrosurg Electro W/non-Stick Coat	Alto Development Corp	GEI	Class II	1993-09-07
K931356	Safe Air Vari-Spot Handpiece Telescope and Adaptor	Sorenson Laboratories, Inc.	LQJ	Class II	1993-09-07
K931314	Konica Qx-70 Automatic X-Ray Film Processor	Konica Medical Corp.	IXW	Class II	1993-09-07
K931313	Konica Qx-130Aplus Automatic X-Ray Film Processor	Konica Medical Corp.	IXW	Class II	1993-09-07
K931312	Konica Srx-101 Automatic X-Ray Film Processor	Konica Medical Corp.	IXW	Class II	1993-09-07
K931138	Core Dynamics Laparoscipic Irrigation Pump	Core Dynamics, Inc.	GCJ	Class II	1993-09-07
K930811	Modified Body Helmholtz Coil	Siemens Medical Solutions USA, Inc.	LNH	Class II	1993-09-07
K930635	Multistar D Angiographic X-Ray System	Siemens Medical Solutions USA, Inc.	IZI	Class II	1993-09-07
K930463	Locking Pivotal Thoracoport	Surgical Technologies, Inc.	GCJ	Class II	1993-09-07
K930337	Profast(r)-Denture Cleanser	Fittydent-Altwirth & Schmitt GmbH	EFT	Class I	1993-09-07
K930213	Model Asym-100	Nucletron Mfg. Corp.	KPQ	Class II	1993-09-07
K925360	Es-100 Power System, Es-100 Series	Elekta Instruments, Inc.	GEY	Class I	1993-09-07