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 2095 of 3531

510(k) clearances, page 2095 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K951393	Abacus Ob Ultrasoung Computer Software	Solomon Technology Labs	HEM	Class II	1995-05-01
K950130	Micro-Endo(tm) Instruments	Sofamor Danek USA,Inc.	HRX	Class II	1995-05-01
K945152	Mechanical Wheelchair- Impact	Colours 'N Motion	IOR	Class I	1995-05-01
K943980	Il Test Phenytion Calibrators	Instrumentation Laboratory Co.	DIP	Class II	1995-05-01
K943279	Accumeter Hdl Cholesterol Test	Chemtrak, Inc.	LBS	Class I	1995-05-01
K942836	Fingerprint-Doa	Fingerprint Bioteck, Inc.	DKZ	Class II	1995-05-01
K941924	Elvis Hsv	Ortho-Clinical Diagnostics, Inc.	GQN	Class II	1995-05-01
K936040	Hypo(r) Safety Cartridge Syringe	Smith & Nephew, Inc.	MEG	Class II	1995-05-01
K935368	Stc Diagnostic 8000	Sherman Technology Corp.	IKN	Class II	1995-05-01
K951504	Sunnex Fashion Corp. Non-Prescription Sunglasses	Sunnex Fashion Corp.	HQY	Class I	1995-04-28
K951468	Comfit	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1995-04-28
K951467	Ultimax	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1995-04-28
K951456	Scipotex (Blue)	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1995-04-28
K951455	Scipotex (Pink)	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1995-04-28
K951327	Comfeel Plus Contour Dressing	Richard Hamer Assoc., Inc.	KMF	Class I	1995-04-28
K951103	Silastic Brand Foley Catheter	C.R. Bard Inc	EZL	Class II	1995-04-28
K950799	Pro-Vit	M. Imonti and Associates Inc.	HQE	Class II	1995-04-28
K950535	Scimed Sceptor Exchange Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1995-04-28
K950534	Scimed Sceptor Ptca Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1995-04-28
K950352	Preceder Guidewire	Boston Scientific Corporation	DQX	Class II	1995-04-28
K946114	Sensori-Motor Rating Scale	Cmed	IXY	Class I	1995-04-28
K945785	Scipotex	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1995-04-28
K945467	Babytherm 8000 Wb	Drager, Inc.	ILO	Class II	1995-04-28
K945078	Hemochron Hnpt/factor VI Pt+	Accriva Diagnostics, Inc.	GJS	Class II	1995-04-28
K944558	Ellman Vapor-Vac II	North American Technical Services Corp.	GEX	Class II	1995-04-28
K944385	Md400 A/b/c/d/e/f/g	International Purification Systems, Inc.	FIP	Class II	1995-04-28
K944353	Simon Nitinol Filter	Nitinol Medical Technologies, Inc.	DTK	Class II	1995-04-28
K944267	Heat Exchanger Modification for Duo and Optima	LivaNova USA, Inc.	DTR	Class II	1995-04-28
K943692	Smart Dose(tm)	River Medical, Inc.	FRN	Class II	1995-04-28
K940724	None-Generic	Top Fashion Optical & Sunglasses	HQY	Class I	1995-04-28
K935909	Cg-1000 Personal ECG Transmitter	Card Guard Scientific Survival, Ltd.	DXH	Class II	1995-04-28
K930868	Dyna Implant Design	Dyna Dental Engineering BV	DZE	Class II	1995-04-28
K951652	Ventimask Mk IV	Flexicare Medical Ltd.	BYF	Class I	1995-04-27
K951381	Vila	Health-Dent Intl., Inc.	DYH	Class II	1995-04-27
K951380	Vila Pc	Health-Dent Intl., Inc.	DYH	Class II	1995-04-27
K951379	Resound Personal Hearing System Models Ed3a & Ed3a/s W/remonte Control Option	Resound Corp.	ESD	Class I	1995-04-27
K951378	Resound Personal Hearing System Models Btp2 & Btp2/s W/remote Control Option	Resound Corp.	ESD	Class I	1995-04-27
K951095	10.5Mm Replica Hip Stem	Depuy, Inc.	LPH	Class II	1995-04-27
K950700	Bard Bilisystem Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula	C.R. Bard Inc	ODD	Class II	1995-04-27
K950522	Cahp High Performance Cellulose Diacetate Hollow Fiber Dialyzer	Baxter Healthcare Corporation	KDI	Class II	1995-04-27
K950511	Bll-Fil 6140 Particles	Bio-Interfaces, Inc.	LYC	Class II	1995-04-27
K950454	Cahp High Performance Cellulose Diacetate Hollow Fiber Dialyzer	Baxter Healthcare Corporation	FJI	Class II	1995-04-27
K950365	Moyco-Edta	Union Broach, Div. Moyco Industries, Inc.	KJJ	Unclassified	1995-04-27
K950300	Bard Flexible Tip Ureteral Catheter	C.R. Bard Inc	EYB	Class II	1995-04-27
K946060	Remington Medical Disposable Fluoro/equipment Cover Model Rmi8	Remington Medical	KKX	Class II	1995-04-27
K945634	Imx(r) Toxo Igm	Abbott Medical	LGD	Class II	1995-04-27
K945371	Compel 3000 Surgical Gown, Compel 2G Surgical Gowns	Standard Textile Co., Inc.	FYA	Class II	1995-04-27
K944992	Electrodes	Linvatec Corporation	JOS	Class II	1995-04-27
K944886	Colgate Precision Mint Wzxed Dental Floss	Colgate-Palmolive Company	JES	Class I	1995-04-27
K944620	Series 400 Gastroenterology System	Marks & Murase	FET	Class II	1995-04-27