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 2006 of 3531

510(k) clearances, page 2006 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K960124	Sas Salmonella 0 Factor 10 Antiserum And/or Sas Salmonella 0 Group E1 Factor 10 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960123	Sas Salmonella O Factor 18 Antiserum &/or Sas Salmonella O Group K Factor 18 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-06
K960009	Storz S2050 Series Bipolar Forceps	Storz Instrument Co.	GEI	Class II	1996-03-06
K955903	Selfcare Early Pregnancy Test	Cambridge Diagnostics Ireland, Ltd.	LCX	Class II	1996-03-06
K955671	Ritleng Bican.lacr.sets/self Thread. Monokas(chg.in Ster.)	G.W.B. Intl., Ltd.	OKS	Unclassified	1996-03-06
K955670	Dermatouch Latex Gloves	Concordia Research Lab	LYY	Class I	1996-03-06
K955656	North State Plastics Aerosol Tee	North State Plastics, Inc.	BYX	Class I	1996-03-06
K955595	Safeline Multidose Vial Adapter	Mcgaw, Inc.	LHI	Class II	1996-03-06
K955594	Safeline i.v. Bag Access Device	Mcgaw, Inc.	LHI	Class II	1996-03-06
K955481	Theratest Kit (Modification)	Theratest Laboratories, Inc.	LJM	Class II	1996-03-06
K954747	Niomed Barrier Gowns	Amerasia Corp.	FYC	Class II	1996-03-06
K954498	Frontline Opiates	Boehringer Mannheim Corp.	DJG	Class II	1996-03-06
K954497	Frontline Cannabis	Boehringer Mannheim Corp.	LDJ	Class II	1996-03-06
K954496	Frontline Cocaine	Boehringer Mannheim Corp.	DIO	Class II	1996-03-06
K954095	Medicool (Modificaton)	Microclimate Systems, Inc.	ILO	Class II	1996-03-06
K953838	Myocardial Protection System	Quest Medical, Inc	DTR	Class II	1996-03-06
K951514	Ssc Model 4000 Series	Ssc Medical Products, Inc.	FNL	Class II	1996-03-06
K944458	Accu-Chek Instant Plus Choloesterol Test	Boehringer Mannheim Corp.	CHH	Class I	1996-03-06
K960554	Detachatip Thoracoscopic Scissors	Microsurge, Inc.	GEI	Class II	1996-03-05
K960181	Version 3.7 Operating System Software	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1996-03-05
K955892	Hydrocolloid Tray Materials, Med. to High Viscosity/wash Materials, Low Viscosity	Van R Dental Products, Inc.	ELW	Class II	1996-03-05
K955731	Osteonics Shoulder Humeral Components	Osteonics Corp.	KWS	Class II	1996-03-05
K955655	Midwest One	Midwest Dental Products Corp.	EFB	Class I	1996-03-05
K955559	Corometrics Fetal Movement Detection Kit	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1996-03-05
K952536	Sono 5	Zimmer Elektromedizin GmbH	IMI	Class II	1996-03-05
K943403	Condor Ultrasonic Inserts	Condor Products, Inc.	ELC	Class II	1996-03-05
K931647	Phoenix 4.0 Mm Ha Coated Dental Implant	Vancouver Implant Center	DZE	Class II	1996-03-05
K960628	Lanard, Radio Shades, Sun Shades, Cool Shades, Kool Loops, Solar Spex, Shade Zone	Lanard Toys, Ltd.	HQY	Class I	1996-03-04
K960610	Sas Salmonella H Z15 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-04
K960609	Sas Salmonella H Z32 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-04
K960603	Sas Salmonella H Z23 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-04
K960530	Arnet or Arnette	Arnet Optic Illusions	HQY	Class I	1996-03-04
K960335	Sas Salmonella H Poly a-Z Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-04
K960333	Sas Salmonella H G,p,u Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-04
K960331	Sas Salmonella H Z28 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-04
K960328	Silk Nonabsorbable Surgical Sutures Usp	R. K. Medical L. L. C.	GAP	Class II	1996-03-04
K960327	Nylon Noabsorbable Surgical Sutures Usp	R. K. Medical L. L. C.	GAR	Class II	1996-03-04
K960133	Sas Salmonella H F Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-04
K960131	Sas Salmonella H G Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-04
K955933	Buffard Creation (Sunglasses)	Buffard Creation Eurl	HQY	Class I	1996-03-04
K955837	Cannulated Plus Hip Screw (Sterile)	Wrightmedicaltechnologyinc	HWC	Class II	1996-03-04
K955768	Biofix Biodegradable Meniscus Arrow System	Bioscience, Inc.	MAI	Class II	1996-03-04
K955710	J.b.s. T.t.a Screw	J.B.S. (USA), Inc.	HWC	Class II	1996-03-04
K955676	Synchron Systems Methaqualone Reagent	Beckman Instruments, Inc.	KXS	Class II	1996-03-04
K955554	Hemo-Valve	North American Instrument Corp.	DTL	Class II	1996-03-04
K955540	Hand Held Atlas Instrument	Spinalight Inc	LXM	Unclassified	1996-03-04
K954816	Storz Dp4800 Deluxe , Storz Dp4801 Basic W/reflux, Dp4801 Basic Posterior Vitrectomy Pack with Variable Port Cutter & Rx	Storz Instrument Co.	HQE	Class II	1996-03-04
K953850	Redox	KCI USA, Inc.	JOW	Class II	1996-03-04
K952151	Storz Ophthalmic Bipolar Cautery Instruments (D8200, D8201, D8203) and Bipolar Cords (D8202, D8204)	Storz	HQR	Class II	1996-03-04
K952042	Travel Ease Electric Scooter, Model: Pioneer	Merits Health Products, Inc.	INI	Class II	1996-03-04