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 3401 of 3526

510(k) clearances, page 3401 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K790845	Dualume Laryngeal Examination Telescope	National Medical Technology	ENZ	Class II	1979-07-24
K790795	Model 4000, Spectrophotometer	Revvity Health Sciences, Inc.	JXR	Class I	1979-07-24
K790667	Corning Paraprotein Screening	Corning Medical & Scientific	CFF	Class II	1979-07-24
K790630	Ria, Insulin, Double Antibody	Endocrine-Metabolic Center	CFP	Class I	1979-07-24
K782162	Battery Charger, 171 Pacemaker	Telectronics, Inc.	DXY	Class III	1979-07-24
K782161	Pulse Generator, Model 171	Telectronics, Inc.	DXY	Class III	1979-07-24
K791292	Brain Heart Infusion with Agar Broth	Isle Media and Sterile Products, Inc.	JSC	Class I	1979-07-17
K791291	Brain Heart Infusion with Broth	Isle Media and Sterile Products, Inc.	JSC	Class I	1979-07-17
K791194	Brain Heart Infusion Broth	Isle Media and Sterile Products, Inc.	JSC	Class I	1979-07-17
K791193	Nutrient Broth	Isle Media and Sterile Products, Inc.	JSC	Class I	1979-07-17
K791189	Echo Cardiogram Pad	Alimed, LLC	FNJ	Class I	1979-07-17
K791171	Tryptic Soy Broth	Isle Media and Sterile Products, Inc.	JSC	Class I	1979-07-17
K791143	Sickle-Cell F Test	Isolab, Inc.	KQI	Class II	1979-07-17
K791129	Permanent Lead Intraducer	Daig Corp.	DYB	Class II	1979-07-17
K791126	Model Ce-Dm-II Hearing Instrument	Marcon Hearing Instruments, Inc.	ESD	Class I	1979-07-17
K791108	Context Filter	Geometric Data, Div. Smithkline Corp.	GKZ	Class II	1979-07-17
K791102	Cary 210 Series, Spectrophotometer	Varian Assoc., Inc.	JJQ	Class I	1979-07-17
K791085	Plus Chem, Determination of Ld (Ldh-P)	Smithkline Diagnostics, Inc.	CFJ	Class II	1979-07-17
K791084	Plus Chem, Determination of Alt (Gpt)	Smithkline Diagnostics, Inc.	CKA	Class I	1979-07-17
K791083	Spin Chem, Determination of Alt (Gpt)	Smithkline Diagnostics, Inc.	CKA	Class I	1979-07-17
K791082	Spin Chem Reagent, Determination of Ast	Smithkline Diagnostics, Inc.	CIT	Class II	1979-07-17
K791081	Spin Chem Reagent, Determination of Ldh-	Smithkline Diagnostics, Inc.	CFJ	Class II	1979-07-17
K791079	Gammadab (125 1) Folate Radioassay Kit	Clinical Assays, Inc.	CGN	Class II	1979-07-17
K791059	Pope Oto-Wick, Sterile & Non-Sterile	Xomed, Inc.	KCN	Class I	1979-07-17
K791031	Abnormal Protein Electrophoresis Control	Beckman Instruments, Inc.	JJX	Class I	1979-07-17
K791029	Normal Protein Electrophoresis Control	Beckman Instruments, Inc.	JJX	Class I	1979-07-17
K791018	Fermcotest R Bun Rate Reagent Test Kit	Fermco Biochemics, Inc.	CDS	Class II	1979-07-17
K790985	P.a.p. Ria Control Serum Pack	Mallinckrodt Critical Care	JJT	Class I	1979-07-17
K790876	Labeled Human Chorionic Gonadotrophin	Pcl-Ria, Inc.	JHI	Class II	1979-07-17
K790864	Rabbit Antiserum to Human Chorionic	Pcl-Ria, Inc.	JHI	Class II	1979-07-17
K790863	Human Chorionic Gonadotrophin Standards	Pcl-Ria, Inc.	JHI	Class II	1979-07-17
K790816	Hematrak Model 480	Geometric Data, Div. Smithkline Corp.	GKZ	Class II	1979-07-17
K790797	Amylase Reagent Set	Alta Diagnostics, Inc.	KHM	Class II	1979-07-17
K790796	Lipase Reagent Set	Alta Diagnostics, Inc.	CET	Class I	1979-07-17
K790339	Concept II	Richardson Merrel, Inc.	EBE	Class II	1979-07-17
K791183	Swan-Ganz Flow-Directed Catheter	Edwards Lifesciences LLC	LDF	Class II	1979-07-12
K780627	Surg-O-Pak, Gowns, Sheets, and Towels	Convertors	KKX	Class II	1979-07-11
K791166	Dexide Disposable Prep Sponge	Dexide, Inc.	NAB	Class I	1979-07-10
K791165	Arcolith 4000	Arco Medical Products Co.	DXY	Class III	1979-07-10
K791145	CPR Control System	Pepin Distributing, Inc.	DRM	Class II	1979-07-10
K791140	Pregelled Disposable Eelctro. Series 600	Hayes Products, Inc.	DRX	Class II	1979-07-10
K791139	Pregelled Disposable ECG Electrodes	Hayes Products, Inc.	DRX	Class II	1979-07-10
K791123	Ear and Nose Specula	Xomed, Inc.	EPY	Class I	1979-07-10
K791122	Tissure Retractors	Xomed, Inc.	GAD	Class I	1979-07-10
K791120	Middle Ear Picks, Hooks Curettes,	Xomed, Inc.	GDG	Class I	1979-07-10
K791089	Sherwood Nebulizer Kit	Sherwood Medical Co.	CAF	Class II	1979-07-10
K791054	Hyper Chec, Sphygmomanometer Electronic	C.R. Bard Inc	DXN	Class II	1979-07-10
K790983	Biflex Tm Temporary Pacing Probe	Advanced Medical Concepts, Inc.	DTB	Class III	1979-07-10
K790597	Sensomat Sidearm Adapter	Biochem International, Inc.	KGZ	Class I	1979-07-10
K791190	Stethoscope with Temperature Sensor	National Catheter Co. Div. Mallinckrodt	BZT	Class II	1979-07-06