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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2976 of 3529

510(k) clearances, page 2976 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K851825	Scanlan Tunneler, Sheath & Tip	Scanlan Intl., Inc.	DWS	Class I	1985-07-12
K851650	Phadebact Monoclonal Gc Omni Test	Pharmacia, Inc.	LIC	Class II	1985-07-12
K851637	Sirecust 425, Respectively Sirecust 430	Siemens Medical Solutions USA, Inc.	DQK	Class II	1985-07-12
K851508	Nikon/joyce Lock Magican 2 Chromosome Sys	Nikon, Inc.	LNJ	Class II	1985-07-12
K851432	Hemoglobin	Horiba Instruments Incorporated	KHG	Class II	1985-07-12
K851426	Accucom Cardiac Output Monitor	Lawrence Medical Systems, Inc.	DXK	Class II	1985-07-12
K851393	Dupont Prep Four-Solvent Retrofit Kit	E.I. Dupont de Nemours & Co., Inc.	JJH	Class I	1985-07-12
K851375	Tri-Count	Hematology Marketing Assoc.	JPK	Class II	1985-07-12
K851372	Cellmatics Herpes Simplex Virus Detect-Sys	Difco Laboratories, Inc.	GQL	Class II	1985-07-12
K852684	Waldmann F85/100w Uv21	Sylvania Lighting Products	FTC	Class II	1985-07-11
K852661	Apollo Sterile Blades	Orthofab, Inc.	GES	Class I	1985-07-11
K852576	Waldmann F85/100w Uv6	Sylvania Lighting Products	FTC	Class II	1985-07-11
K852541	Storz Ion Bond Osteotomes & Rasps, Fast Cu Burs	Storz Instrument Co.	GFI	Class I	1985-07-11
K852501	Myelogram Procedure Tray	Manan Manufacturing Co., Inc.			1985-07-11
K852402	Namic Homer Mammalok Needle/wire Localizer	North American Instrument Corp.	FZX	Class I	1985-07-11
K852375	i.v. Starter Tray W/dynaderm Transparent Adhesive	Ferris Mfg. Corp.	LRS	Class II	1985-07-11
K852321	Sylvania F8t5/puva & Waldmann F15t8/puva	Sylvania Lighting Products			1985-07-11
K852236	Medtronic Model 5867-1A	Medtronic, Inc.	KFJ	Class III	1985-07-11
K852095	Esp Emergency Care Kit	Emergency Situation Products			1985-07-11
K852018	Arthrogram Tray for Double & Single Contrast Arthr	Manan Manufacturing Co., Inc.			1985-07-11
K851834	Manan Gwi Guide Wire Introducer	Manan Manufacturing Co., Inc.	DWS	Class I	1985-07-11
K851833	Manan Seldinger Needle	Manan Manufacturing Co., Inc.	DWS	Class I	1985-07-11
K851832	Naman Potts Cournand Needle	Manan Manufacturing Co., Inc.	DWS	Class I	1985-07-11
K851461	Implantable Electrode Adaptor Assemble	Telectronics, Inc.	DTB	Class III	1985-07-11
K851458	Model 493-04 Polyflex R Implantable Pacing Lead	Intermedics, Inc.	DTD	Class II	1985-07-11
K851457	Model 483-06 Polyflex Implantable Pacing Lead	Intermedics, Inc.	DTD	Class II	1985-07-11
K851077	Cardiac Cooling Jacket	Pat O. Daily	KRI	Class I	1985-07-11
K851040	Concept Defrere Electrode	Concept, Inc.	GEI	Class II	1985-07-11
K850705	The White River Porta-Elec-Breast Pump	Natural Technologies, Inc.	HGX	Class II	1985-07-11
K843731	Kenz 80Z Mark II	Suzuken Co., Ltd.	DSI	Class II	1985-07-11
K852268	Quanticlone Ige Radioimmunassay	Kallestad Laboratories, Inc.	DGC	Class II	1985-07-10
K852247	Laser Ceruloplasmin Kit(ceruloplasmin Reagents)	Behring Diagnostics, Inc.	DDB	Class II	1985-07-10
K852231	Ana/lite-Hep-2 Test System	Immuno-Products Industries	LJM	Class II	1985-07-10
K852230	Ana/lite-Rl Test System	Immuno-Products Industries	LJM	Class II	1985-07-10
K851389	Apo B Ria Kit	Iso-Tex Diagnostics	MSJ	Class I	1985-07-10
K850785	Fastube Nerve Regeneration Device	Research Medical, Inc.	JXI	Class II	1985-07-10
K852726	Allis Tissue Forceps, 4X5 Teeth, 6+Ss 410 or 420	The Huxley Instrument Corp.	KOA	Class I	1985-07-09
K852725	Babcock Tissue Forceps, 6-1/4 + Ss 410 or 420	The Huxley Instrument Corp.	KOA	Class I	1985-07-09
K852577	Rubin Disposable Cartilage Planner	Frank F. Rubin			1985-07-09
K852567	3M Fukuda Type Ring Retractor	3M Company	GAD	Class I	1985-07-09
K852480	Derm-Kit	Culture Kits, Inc.	JSI	Class I	1985-07-09
K852376	Simultaneous Lh/fsh System by Ria	American Bioclinical, Inc.	CEP	Class I	1985-07-09
K852343	Dig Radioimmunoassay Test System	M Nobird, Inc.	DNL	Class II	1985-07-09
K852320	Cobas Fp Reagen for Procainamide & Pro Calibrator	Roche Diagnostic Systems, Inc.	LAR	Class II	1985-07-09
K852299	Terumo Sensibead Eia Hgh Kit	Terumo Medical Corp.	CFL	Class I	1985-07-09
K852286	Dirrect Agglutination(dag) Pregnancy Test	Sero-Immuno Diagnostics, Inc.	JHJ	Class II	1985-07-09
K852285	Dade Blood Gas Ampul Injector	American Dade	JQW	Class I	1985-07-09
K852280	Drapes(surgical, General & Plastic Surgery)	Outpatient Products Co.	KKX	Class II	1985-07-09
K852224	Lee-Bead Tsh(eia)	Lecco Diagnostics, Inc.	JLW	Class II	1985-07-09
K852183	Beta Hcg Extended Range Accessory Kit	Abbott Medical	JHI	Class II	1985-07-09