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 3370 of 3526

510(k) clearances, page 3370 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K792553	Agarose Barbital-Edta Buffer	Electrophoresis Corp. of America	JJN	Class I	1980-01-29
K792551	Alkaline Phosphatase Reagent	Electrophoresis Corp. of America	CJH	Class II	1980-01-29
K792548	Alkaline Phosphatase Marker	Electrophoresis Corp. of America	CIN	Class II	1980-01-29
K792547	Agarose Barbital Buffer	Electrophoresis Corp. of America	JJN	Class I	1980-01-29
K792545	Uric Acid Kit	Alta Diagnostics, Inc.	KNK	Class I	1980-01-29
K792537	Coulter Counter Model S Plus	Coulter Electronics, Inc.	GKL	Class II	1980-01-29
K792066	M.p.i. Lens Glide	J. Leon Bilby	KYB	Class I	1980-01-29
K800103	Surgical Stitch Cutter	Macon & Co., Inc.	FZT	Class I	1980-01-28
K800102	Stanford Sterile Lap Sponges	Lukens Corp.	GDY	Class I	1980-01-28
K800081	Davol/abamson Silicone Sump Drain	Davol, Inc.	GCY	Class I	1980-01-28
K800080	Sterilizing Case Cat. No. 65199	Edward Weck, Inc.	FLE	Class II	1980-01-28
K800079	Hemoclip Surgical Occluding Clip	Edward Weck, Inc.	FZP	Class II	1980-01-28
K800076	Crutch Tips, Pads & Hand Grips	New World Imports, Inc.	INP	Class I	1980-01-28
K800074	Vessel Occluder	Cordis US Corp.	GDJ	Class I	1980-01-28
K800072	Digital Electronic Exerciser/pulse Mtr.	Sears, Roebuck & Co.	ISD	Class II	1980-01-28
K800058	Anago Electro Surgical Tip Cleaner	Anago, Inc.	GEC	Class I	1980-01-28
K800051	Hexcel Femoral Component Hip Prosthesis	Hexcel Medical	JDG	Class II	1980-01-28
K792710	Para-Pak Clean Vial	Meridian Diagnostics, Inc.	FMH	Class I	1980-01-28
K792674	Campy Blood Agar	Regional Media Laboratories	JSJ	Class I	1980-01-28
K792650	Hamas Precentered Total Wrist	Zimmer GmbH	JWJ	Class II	1980-01-28
K792645	Trioskop	Siemens Corp.	IXR	Class II	1980-01-28
K792642	The Variable Load Kenetic Energizer	W.F. Pogue	ION	Class I	1980-01-28
K792641	Hydro Pulse Massage	Hydro-Pulse Research, Inc.	ILJ	Class II	1980-01-28
K792638	High Resolution Imaging System	Unirad Corp.	IYO	Class II	1980-01-28
K792631	Sterilization Process/dbl. Grip Cord Clp	Procter & Gamble Mfg. Co.	KNA	Class II	1980-01-28
K792627	Sterilization Process/maternity Pad	Procter & Gamble Mfg. Co.	HIL	Class II	1980-01-28
K792603	Computed Tomography X-Ray Scanner	Ohio Nuclear, Inc.	JAK	Class II	1980-01-28
K792568	Obstetrical Beds	Ets Rene Marzet	KNC	Class II	1980-01-28
K792535	Portaray	Siemens Corp.	EAP	Class II	1980-01-28
K792326	Hilo Trans-X Trauma Transport	Tecnomed, Inc.	IXR	Class II	1980-01-28
K800125	Ventilator Test Lung	Bio-Med Devices, Inc.	CBK	Class II	1980-01-24
K800083	Nebulizer Tubing Set	Abbott Medical	CAF	Class II	1980-01-24
K800056	Ventilator Set	Abbott Medical	BTT	Class II	1980-01-24
K800050	Anitomic Total Hip System	Hexcel Medical	JDG	Class II	1980-01-24
K792722	Novametrix CPAP Nasal Cannula	Novametrix Medical Systems, Inc.	BZD	Class II	1980-01-24
K792716	Candida Albicans, Antigen	Meridian Diagnostics, Inc.	GMI	Class II	1980-01-24
K792714	Para-Pak Pva	Meridian Diagnostics, Inc.	IFQ	Class I	1980-01-24
K792709	Koh Mounting Fluid W/glycerol	Meridian Diagnostics, Inc.	KEQ	Class I	1980-01-24
K792706	Para-Pak(wheatley's Trichrome Stain)	Meridian Diagnostics, Inc.	HYW	Class I	1980-01-24
K792703	Lacto-Phenol Analine Blue Fluid	Meridian Diagnostics, Inc.	KEQ	Class I	1980-01-24
K792702	Vaspar Sealant	Meridian Diagnostics, Inc.	KEQ	Class I	1980-01-24
K792699	Ouchterlony Agar Plates	Meridian Diagnostics, Inc.	JZQ	Class I	1980-01-24
K792697	Normal Globulin Reagent	Meridian Diagnostics, Inc.	DHR	Class II	1980-01-24
K792695	Anti-Globulin Control	Meridian Diagnostics, Inc.	DHR	Class II	1980-01-24
K792694	Negative Control Serum	Meridian Diagnostics, Inc.	GMK	Class II	1980-01-24
K792692	Immunodiffusion Band Intensifying Fluid	Meridian Diagnostics, Inc.	GMK	Class II	1980-01-24
K792676	Campy Thio	Remel Co.	JSJ	Class I	1980-01-24
K792656	Helena Factor XII Deficient	Helena Laboratories, Corp.	GGP	Class II	1980-01-24
K792655	Helena Coloscreen	Helena Laboratories, Corp.	KHE	Class II	1980-01-24
K792654	Culturette Brand-Pva/formalin Kit	Marion Laboratories, Inc.	IFQ	Class I	1980-01-24