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 3420 of 3526

510(k) clearances, page 3420 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K790079	Needle, Blood Collecting	Jelco Laboratories	GAA	Class I	1979-02-01
K790076	Inoculator, Mic-2000 Disposable	Dynatech Laboratories, Inc.	JTC	Class I	1979-02-01
K790034	Introducers	Clincal Instruments Corp.	DYB	Class II	1979-02-01
K790032	Disposable Vacuum Curette	British Marketing Ent., Ltd.	HCY	Class I	1979-02-01
K790018	Serum, Potassium Determination of	Fisher Scientific Company L.L.C.	CEM	Class II	1979-02-01
K790010	Manifold, Disposable 3 Valve	Cordis US Corp.	FMG	Class II	1979-02-01
K790002	Pregnancy Test Kit, Daisy 2 in Home	Boehringer Mannheim Corp.	JHJ	Class II	1979-02-01
K782159	Diagnostic Kit, Ferritab-Fe-59	Leeco Diagnostics, Inc.	JJA	Class I	1979-02-01
K782117	Martin-Lewis Medium	Prepared Media Laboratory, Inc.	JTY	Class II	1979-02-01
K782115	Astra-Vac	Ab Astra	GCY	Class I	1979-02-01
K782086	Am-Pen Screen	Pfizer Inc	JTO	Class I	1979-02-01
K782085	Emit Thyroxine Assay	Syva Co.	KLI	Class II	1979-02-01
K782079	Electrode System, Quik-Prep	Quinton, Inc.	DRX	Class II	1979-02-01
K782070	Reagent, Cocci Latex	I M, Inc.	GMG	Class II	1979-02-01
K782015	A-Gent Ck-Mb	Abbott Medical	JHW	Class II	1979-02-01
K781953	Ria Kit, Immo Phase	Corning Medical & Scientific	JLW	Class II	1979-02-01
K781930	Pant Liner, Disp. Incontinent	Fibre Formations, Inc.	EYQ	Class I	1979-02-01
K781570	Sutureless Muocardine Pacing Leads 471	Intermedics, Inc.	DTB	Class III	1979-02-01
K781525	Endocaridal Pacing Lead Unipolar 477	Intermedics, Inc.	DTB	Class III	1979-02-01
K781499	Lifeline Pacing Lead Model 467-01	Intermedics, Inc.	DTB	Class III	1979-02-01
K781498	Lifeline Bipolar Pacing Lead Mod. 466-01	Intermedics, Inc.	DTB	Class III	1979-02-01
K781497	Lifeline Pacing Lead Model 465-01	Intermedics, Inc.	DTB	Class III	1979-02-01
K771988	Vertetrac	Ballert Orthopedic Corp.	HST	Class I	1979-02-01
K782145	Spirometer, Mini Positive	Boehringer Laboratories, LLC	BZK	Class II	1979-01-31
K782138	Monitor, Beckman Lb-3Co2	Beckman Instruments, Inc.	CCK	Class II	1979-01-31
K790221	Pulse Generator, Cyberlith Implantable	Intermedics, Inc.			1979-01-30
K781805	Cardiac Computers, Co-10 & Co-10R	Waters Assoc., Inc.	DXG	Class II	1979-01-29
K790126	Valve, H-H Cruciform Slit	Holter-Hausner Intl.	JXG	Class II	1979-01-26
K790095	Module Personal Ear (Deluxe)	Qualitone	ESD	Class I	1979-01-26
K790094	Module Personal Ear (Compression)	Qualitone	ESD	Class I	1979-01-26
K790093	Module Personal Ear (Super)	Qualitone	ESD	Class I	1979-01-26
K790081	Camera, Cleon 720 Large Field Gamma	Union Carbide Corp.	IYX	Class I	1979-01-26
K790080	Apron, Leaded Vinyl	Pinnacle Distributors, Inc.	KPY	Class I	1979-01-26
K790070	Siregraph B-150	Siemens Corp.	KPR	Class II	1979-01-26
K790069	Buckymat	Siemens Corp.	KPR	Class II	1979-01-26
K790053	Kelley-Plus with Measurette	John N. Haswell, M.D.	KKX	Class II	1979-01-26
K790046	G-Hb Quik Column Control	Helena Laboratories, Corp.	LCP	Class II	1979-01-26
K790038	Disk, Beta-Lactam	Remel Co.	JTO	Class I	1979-01-26
K790037	Sono Trak T.m.	Narco Air-Shields	IYO	Class II	1979-01-26
K790012	Rheumogen Test System	Calbiochem-Behring Corp.	DHR	Class II	1979-01-26
K782176	Hycel Ldh-Int Test	Hycel, Inc.	CFH	Class II	1979-01-26
K782160	Total Iron in Serum	Fisher Scientific Company L.L.C.	JIY	Class I	1979-01-26
K782142	Illiminator, Model 265 Nasal	Welch Allyn Inc	ERA	Class I	1979-01-26
K782141	Levigator, Keeler Phoko	Keeler Optical Products, Ltd.	HQC	Class II	1979-01-26
K782136	Glucose Reagent System	American Monitor Corp.	CFR	Class II	1979-01-26
K782118	Ful-Vue	American Optical Corp.	HKN	Class I	1979-01-26
K782116	Ketosteroid Test, Hycel-17	Hycel, Inc.	CCY	Class I	1979-01-26
K782110	Ria Kit, Rianen Cortisol	New England Nuclear	CGR	Class II	1979-01-26
K782109	Ria Kit, Gammacoat	Clinical Assays, Inc.	CDX	Class II	1979-01-26
K782096	Instruments, Overrefraction System	Zeiss Humphrey System	HLM	Class I	1979-01-26