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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3416 of 3526

510(k) clearances, page 3416 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K790287	Analyzer, Medilog II	Oxford Medilog, Inc.	DSI	Class II	1979-02-28
K790004	Monitor Scopes, Models 9502, 9503	C-V Monitors Corp.	DRT	Class II	1979-02-28
K782024	Ria Kit, Vitamin B12	Technia Diagnostics, Ltd.	CDD	Class II	1979-02-28
K790335	Hycel M	Hycel, Inc.	JJF	Class I	1979-02-27
K790304	Preamplifier Module, EKG Respiration	Abbott Medical Electronics Co.	BZQ	Class II	1979-02-27
K790289	Pb-4 Replay Unit	Oxford Medilog, Inc.	DSH	Class II	1979-02-27
K790288	Storage, Digital Dsc-1, Control Unit	Oxford Medilog, Inc.	DXG	Class II	1979-02-27
K790286	Recorder, Medilog II	Oxford Medilog, Inc.	DSH	Class II	1979-02-27
K790270	Hearing Aid Model 8143	Int'L Hearing Aids, Inc.	ESD	Class I	1979-02-27
K790261	Medtronic Temptron	Medtronic, Inc.	DTB	Class III	1979-02-27
K790210	Stockinette, Tubular Unbleached	The Owenby Co.	FQM	Class I	1979-02-27
K790187	Bovie Hand Control	Sybron Corp.	GEI	Class II	1979-02-27
K790172	Bk-5098 Tilt Table Strap	Fred Sammons, Inc.	FMQ	Class I	1979-02-27
K790140	Skin Closure Tapes Sterile	Shur Medical Corp.	FPX	Class I	1979-02-27
K790078	Bar & Rider, Screws, Tubes	Eurodent, Inc.	ECG	Class I	1979-02-27
K790049	Bed, Paraplegic	Wayne V. Kirkman	FNL	Class II	1979-02-27
K790006	Gdc-591	Deringer-Ney, Inc.	EJT	Class II	1979-02-27
K782133	Odontoson 3	Mdt Corp., Inc.	ELC	Class II	1979-02-27
K782058	Catheter, Beta-Cap-Peritoneal	Dravon Medical, Inc.	FJS	Class II	1979-02-27
K782057	Catheter, Radiopaque Tenckhoff	Dravon Medical, Inc.	FJS	Class II	1979-02-27
K782034	Infusion Pump, Model As*5	Baxter Healthcare Corporation	FRN	Class II	1979-02-27
K781815	Hemo-Nate Syringe Blood Filter	Gisco Intl.	FPB	Class II	1979-02-27
K790327	Angio-Flo	Deseret Medical, Inc.	KRA	Class II	1979-02-26
K790326	Drushoe	J.E. Hanger & Co., Ltd.	KNP	Class I	1979-02-26
K790301	Hearing Aid, Oticon I II H	Oticon, Inc.	ESD	Class I	1979-02-26
K790292	Monitor, Electrocardioscope	Burdick Corp.	DRT	Class II	1979-02-26
K790276	Minilith and Microlith	Cardiac Pacemakers, Inc.	DXY	Class III	1979-02-26
K790269	Ceptor Hesive	Med General	GXY	Class II	1979-02-26
K790251	Ful-Vue Aspheric Cataract Lens	American Optical Corp.	HQG	Class I	1979-02-26
K790247	Tourniquet Test Gage	Orthopedic Equipment Co., Inc.			1979-02-26
K790229	Vaginalis, Haemophilus	Los Angeles Biological Products	JSH	Class I	1979-02-26
K790215	Lens, Polycore	Polycore Optical Pte, Ltd.	HQG	Class I	1979-02-26
K790209	Filter System, Altner Disposable	Orthopedic Equipment Co., Inc.	GAZ	Class II	1979-02-26
K790195	Foot Valve	American Safety	GET	Class I	1979-02-26
K790186	Protectivstabilizer	Jelco Laboratories	GBJ	Class I	1979-02-26
K790142	Needle, with Filter	National Patent Development Corp.	GAA	Class I	1979-02-26
K790127	Cement, Ceramco	Johnson & Johnson Professionals, Inc.	EMA	Class II	1979-02-26
K790113	Midwest 1000	Midwest	EFB	Class I	1979-02-26
K790112	Mobile Units, I,ii,iii,iv	Dentsply Intl.	EIA	Class I	1979-02-26
K790097	Salivan & Salivan Brown	Den-Mat Corp.	EJS	Class II	1979-02-26
K790096	Salivan Paraeight Toughness	Den-Mat Corp.	EJS	Class II	1979-02-26
K790090	Determination of Antithrombin III, 885	Sigma Chemical Co.	JBQ	Class II	1979-02-26
K790084	Surgical Ruler and Pen	Devon Industries, Inc.	FZZ	Class I	1979-02-26
K790047	Cardiac Output Computer, Mdel 9520A	Edwards Laboratories	DXG	Class II	1979-02-26
K790029	Fluid, Rhemox W Lysing	Sysmex Corporation	GGK	Class I	1979-02-26
K790019	Serum, Uric Acid Determination	Fisher Scientific Company L.L.C.	CDH	Class I	1979-02-26
K790017	Serum, Glutamic-Oxaloacetic	Fisher Scientific Company L.L.C.	CIT	Class II	1979-02-26
K790008	I Estriol	Cambridge Nuclear Corp.	CGI	Class I	1979-02-26
K790007	I Testoterone	Cambridge Nuclear Corp.	CDZ	Class I	1979-02-26
K782153	Impression Tray, Mdds Custom	Chayet and Sonnenrich, P.C.	EBH	Class I	1979-02-26