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 3483 of 3526

510(k) clearances, page 3483 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K771136	Surgical Head Drape, Disp.	Procter & Gamble Mfg. Co.	KKX	Class II	1977-07-14
K771135	Quantimune Neonatal & Thyroxine Ria	Bio-Rad	CDX	Class II	1977-07-14
K771132	Kenwood Biological Steoiliz. Indicator	Will Ross Co.	FRC	Class II	1977-07-14
K771097	Forcep, Disp., a Clamp	Dravon Medical, Inc.	HTD	Class I	1977-07-14
K771080	Steam Sterilization Indicator	Info-Chem	FRC	Class II	1977-07-14
K771071	Porto-Vac	Cpac, Inc.	JCX	Class II	1977-07-14
K771070	Dry Heat Sterilizer	Cpac, Inc.	KMH	Class II	1977-07-14
K771062	Ebv Test	Gull Laboratories, Inc.	GNP	Class I	1977-07-14
K771050	Hyperalimentation Tray	American Hospital Supply	KKX	Class II	1977-07-14
K771036	Shave Prep Tray	Parke-Davis Co.	KKX	Class II	1977-07-14
K771032	Pouches, Peel Open, Breathable	Surgicot, Inc.	FRG	Class II	1977-07-14
K771018	Trans 2000	Hamilton Industries, Inc.	INK	Class II	1977-07-14
K770953	Monitor, Aeration, Tec-Test	Castle Co.	FRC	Class II	1977-07-14
K770917	Glutamate Oxalacetic Transaminase	The Dow Chemical Co.			1977-07-14
K770909	Enzymatic Cholesterol Reagent Set	American Monitor Corp.	CHH	Class I	1977-07-14
K770902	Colorimetric Determ. Socitrate Dehydro.	Sigma Chemical Co.	JKH	Class I	1977-07-14
K770887	Auto Total Protein for Analyzer	Harleco	CEK	Class II	1977-07-14
K770886	Auto-Enzymatic Glucose for Analyzer	Harleco	CFR	Class II	1977-07-14
K770883	Ultrazyme Plus Got	Harleco			1977-07-14
K770882	Ultrazyme Plus Gpt	Harleco	CKA	Class I	1977-07-14
K770871	Ultrazyme Plus Hbd	Harleco	JMK	Class I	1977-07-14
K770870	Ultrazyme Plus Alp	Harleco	CJE	Class II	1977-07-14
K770852	Syringe, Blood Sampling, Arterial, #4015	Concord Laboratories, Inc.	FMF	Class II	1977-07-14
K770851	Syringe, Blood Sampling, Arterial, #4016	Concord Laboratories, Inc.	FMF	Class II	1977-07-14
K770849	Volumet Infusion Pump, Modifi. of	Sigmamotor, Inc.	FRN	Class II	1977-07-14
K770844	Flucose u.v. Test Kit	Mallinckrodt Critical Care	CFR	Class II	1977-07-14
K770841	Triglyceride Enzymatic Method	Union Carbide Corp.	CDT	Class I	1977-07-14
K770695	Monitor, Bed, Technolics	Technolics, Inc.	KMI	Class I	1977-07-14
K770686	Theratherm	Electro Therapeutic Devices Inc	IRT	Class II	1977-07-14
K771042	Introducer, Cat. #Int-05Fr.	Sorensen Research	DYB	Class II	1977-07-13
K771041	Introducer, Cat. #Int-06Fr.	Sorensen Research	DYB	Class II	1977-07-13
K771009	Electro-Surgical Devices	Deseret Pharmaceutical Co.	GEI	Class II	1977-07-13
K771068	Triglyceride Kit	Environmental Chemical Specialties	JGM	Class II	1977-07-12
K771210	Urogard Urinary Drainage Bag	Terumo America, Inc.	FCN	Class II	1977-07-11
K771192	Lowman Bone Forcep	Edward Weck, Inc.	HTD	Class I	1977-07-11
K771191	Heiss Retractor	Edward Weck, Inc.	GAD	Class I	1977-07-11
K771190	Abramson Trachea Hook & Retractor	Edward Weck, Inc.	GDG	Class I	1977-07-11
K771189	Hot Temp Cautery	Edward Weck, Inc.	HQP	Class II	1977-07-11
K771187	Dermahook #382-805	Edward Weck, Inc.	GDG	Class I	1977-07-11
K771143	Inorganic Phosphorus Standards	Worthington Biochemical Corp.	JIT	Class II	1977-07-11
K771118	Centria Separation Columns Type a	Clinical Diagnostics, Inc.	CEM	Class II	1977-07-11
K771107	Counter 700 & Hc-700 Hemo 0 Ref.	Hycel, Inc.	GKL	Class II	1977-07-11
K771090	Unipak Hemoglobin	Harleco	GKK	Class II	1977-07-11
K771066	Catheter, Sampling, Conduit	Mentor	FEZ	Class II	1977-07-11
K771063	Hsv Test	Gull Laboratories, Inc.	GQL	Class II	1977-07-11
K771015	Vygon Red-O-Pack	Coastal Bend Medical Products, Inc.	GCY	Class I	1977-07-11
K771001	Statzyme Glucose	Worthington Biochemical Corp.	CGA	Class II	1977-07-11
K770981	Lancer Capillary Blood Serum Separator	Sherwood Medical Industries	GIO	Class I	1977-07-11
K770980	Ematology Diluent Reservoir Closure	BD Becton Dickinson Vacutainer Systems Preanalytic	GHO	Class I	1977-07-11
K770889	Burn Dressing Kit	The Owenby Co.	EFQ	Unclassified	1977-07-11