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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3237 of 3528

510(k) clearances, page 3237 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K820133	Mcgaw Fat Emulsion Set	American Mcgaw	FPA	Class II	1982-04-06
K820029	Kallestad Rast Reagents	Kallestad Laboratories, Inc.	DHB	Class II	1982-04-06
K820790	Flexible Proctosigmoidoscope, #Fps-3	American Optical Corp.	FAM	Class II	1982-04-01
K820745	Diascope 2	Medtronic, Inc.	DRT	Class II	1982-04-01
K820723	Kodak Ektachem Clinical Chem. Nh3	Eastman Kodak Company	JID	Class I	1982-04-01
K820722	Kodak Ektachem Clinical Chemistry Slidde	Eastman Kodak Company	JHS	Class II	1982-04-01
K820721	Computerized Interpretation of Arterial	Philip R. Corsello, M.D.	JQP	Class I	1982-04-01
K820717	Monoject Corvac Stat Vac Tube W/throm	Sherwood Medical Co.	JKA	Class II	1982-04-01
K820714	Dow Bilirubin(direct) Determination	The Dow Chemical Co.	CIG	Class II	1982-04-01
K820710	Neonatal Introducer Kit	Norton Performance Plastics Corp.	DYB	Class II	1982-04-01
K820705	Gas-Trak 2 Synthetic Blood Gas Control	United Diagnostics, Inc.	JJS	Class I	1982-04-01
K820701	Nova I Fluids Pack	Shaban Mfg. Co.	JIX	Class II	1982-04-01
K820700	External Standards-Sodiumnpotassium	Shaban Mfg. Co.	JIX	Class II	1982-04-01
K820698	Syva Advance Standardization Kit 01	Syva Co.	JIS	Class II	1982-04-01
K820687	Dupont Automatic Clinical Analyzer	E.I. Dupont de Nemours & Co., Inc.	JJE	Class I	1982-04-01
K820686	Liquisol Progesterone Radioimmuno	Damon Corp.	JLS	Class I	1982-04-01
K820675	Bilirubin(total) Determination Ctms	The Dow Chemical Co.	CIG	Class II	1982-04-01
K820671	Cm10 Central Monitoring System	Medtel Pty., Ltd.	DRT	Class II	1982-04-01
K820652	Exhaled Hydrogen Monitor	Keymed, Inc.			1982-04-01
K820644	Raichem Tm Creatine Kinase Reagent	Reagents Applications, Inc.	CGS	Class II	1982-04-01
K820631	Corning 480 Flame Photometer	Corning Medical & Scientific	JJO	Class I	1982-04-01
K820624	Syn-Optics #5200	Syn-Optics	FET	Class II	1982-04-01
K820614	Roche B-Hcg Standards	Hoffmann-La Roche, Inc.	JHI	Class II	1982-04-01
K820613	Roche B-Hcg Ria	Hoffmann-La Roche, Inc.	JHI	Class II	1982-04-01
K820573	Helena Hemoglobin Detect Column Sys	Helena Laboratories, Corp.	GKA	Class II	1982-04-01
K820565	Male External Catheter	Urocare Products, Inc.	KNX	Class II	1982-04-01
K820540	Olli 565	Kone Instruments, Inc.	DRT	Class II	1982-04-01
K820371	Plastic Connectors	American Pharmaseal Div. Ahsc	BYY	Class II	1982-04-01
K820062	Disposable Plastic Syringe & Needle	Marshall Davis, Inc.	FMF	Class II	1982-04-01
K813522	Automated Blood Pressure Sphygmomanomtr	Vitar	DXN	Class II	1982-04-01
K811927	1F Blocking Antibody(57 Co) Radioassay	Corning Medical & Scientific	LIG	Class II	1982-04-01
K827175	Ars-1000 Radiation Therapy Treatment Planning System	Applied Radiation			1982-03-31
K827122	Delta Plan II Radiation Therapy Planning System	Technicare Corp.			1982-03-31
K820694	Cobe Ppd 1.3L, #18-520-009	Cobe Laboratories, Inc.	FJG	Class II	1982-03-31
K820688	Arrange Tm	General Electric Co.	JAK	Class II	1982-03-31
K820612	Tensoplast Skin Traction Kit	Smith & Nephew, Inc.	HST	Class I	1982-03-31
K820571	Xenamatic Series of Xenon Rebreath Dev	Diversified P.A.	IYT	Class II	1982-03-31
K820535	Laser Gas Mixtures	Union Carbide Corp.	EWG	Class II	1982-03-31
K820492	Spectra305	Ultralite	FTC	Class II	1982-03-31
K820448	Ars-1000	Applied Radiation	IYE	Class II	1982-03-31
K820412	Am. Ph. Sterile Plastic Connecting Tubes	American Pharmaseal Div. Ahsc	BYY	Class II	1982-03-31
K820310	Delta Plan II Radiation Therapy Plan	Technicare Corp.	IYE	Class II	1982-03-31
K813591	Hemofilters	Amicon, Inc.	KDI	Class II	1982-03-31
K813275	Epcom Ems Scan II	Epcom Medical Systems, Inc.	IYO	Class II	1982-03-31
K813182	Datascope Modified #82 Iabp System	Datascope Corp.	DSP	Class II	1982-03-31
K820713	Ballard Medical Products Electro-Surg	Ballard Medical Products	GEI	Class II	1982-03-26
K820640	Hoo2d Seat-Infant	Dhd Medical Products Div. Diemolding Corp.	BYL	Class I	1982-03-26
K820636	Storz #6500 Power Examination Chair	Storz Instrument Co.	GBB	Class I	1982-03-26
K820634	Trichrome Stain	Volu Sol Medical Industries	HYC	Class I	1982-03-26
K820616	Angiotensis I-Squibb Radioimmunoassay	E. R. Squibb & Sons, Inc.	CIB	Class II	1982-03-26