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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3281 of 3528

510(k) clearances, page 3281 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K811250	Electronic Muscle Stimulator	Electrola	IPF	Class II	1981-07-24
K803071	Pla-Mate	Labex, Inc.	GKL	Class II	1981-07-24
K812078	Gonozyme (10 Copies Frwd. W/orig. to Bg)	Abbott Medical	JTY	Class II	1981-07-23
K811966	Visitec Needle Range (General Hospital)	Visitec Co.	FMI	Class II	1981-07-23
K811957	Campypak	BD Becton Dickinson Vacutainer Systems Preanalytic	KZJ	Class I	1981-07-23
K811953	Immophase Insulin (125I) Radioassay	Corning Medical & Scientific	CFP	Class I	1981-07-23
K811939	Vitatron 88	Vitatronics	GZJ	Class II	1981-07-23
K811932	Coat-a-Count Digoxin Ria	Siemens Healthcare Diagnostics Inc.	DPO	Class II	1981-07-23
K811922	45Degrees Swivel Elbow	Dhd Medical Products Div. Diemolding Corp.	BZA	Class I	1981-07-23
K811921	Hitachi 705 Calibrator	Boehringer Mannheim Corp.	JIX	Class II	1981-07-23
K811919	Kodak Ektachem 400 Analyzer	Eastman Kodak Company	JJE	Class I	1981-07-23
K811917	i.v. Admin. Sets for the Amp Mark IV Pmp	American Medical Products LLC	FRN	Class II	1981-07-23
K811912	Helena Vma-Smc Control	Helena Laboratories, Corp.	JJX	Class I	1981-07-23
K811907	Progesterone Direct Ria Kit (125I)	Immunalysis Corporation	JLS	Class I	1981-07-23
K811906	Dhea-Sulfate Direct Ria Kit(125i)	Immunalysis Corporation	JKC	Class I	1981-07-23
K811905	Follicle Stimulating Hormone Direct Ria	Immunalysis Corporation	CGJ	Class I	1981-07-23
K811901	Century Bathing System	Century Manufacturing Co.	FNG	Class II	1981-07-23
K811899	Century Lift Transfer System	Century Manufacturing Co.	FSA	Class I	1981-07-23
K811896	902 Na/k	Corning Medical & Scientific	JGS	Class II	1981-07-23
K811888	Lindholm Anatomical Tracheal Tube	Mallinckrodt Critical Care	BTR	Class II	1981-07-23
K811886	Cesium Diluent 7.5M	Gilford Diagnostics	JGT	Class II	1981-07-23
K811883	King Diagnostics Glucose-O Test	King Diagnostics, Inc.	CGE	Class II	1981-07-23
K811882	King Diagnostics Glucose Test	King Diagnostics, Inc.	CGA	Class II	1981-07-23
K811881	King Diagnostics Total Bilirubin Test	King Diagnostics, Inc.	CIG	Class II	1981-07-23
K811850	Eskaflow Test for Triglycerides	Smithkline Diagnostics, Inc.	CDT	Class I	1981-07-23
K811818	Uropaper Eiken Uag	Syn-Kit, Inc.	JIL	Class II	1981-07-23
K811778	Model 4100 14 Mev Neutron Gen. Therapy	The Cyclotron Corp.	IWL	Class II	1981-07-23
K811680	Accudex	Biodynamics Corp.	JJQ	Class I	1981-07-23
K811570	Antibody to Chlamydia Trachomatis	Electro-Nucleonics Laboratories, Inc.	GPW	Class I	1981-07-23
K811258	Base Metal Alloy	Dentsply Intl.	EJH	Class II	1981-07-23
K811084	Labtronix Platelet Counter(l/o/c.)	Labtronix Corp.	GLG	Class I	1981-07-23
K810694	Phadebas Igg Rast Test	Pharmacia, Inc.	DEW	Class II	1981-07-23
K812038	Oxygen Controller Model 145	Medix Medical Electronics (U.S.A.), Inc.			1981-07-21
K810803	Freeze Dried Papain	Biological Corp. of America	KSK	Class II	1981-07-21
K811992	Assure Natural Fit Tampon	Personal Products Co.	HEB	Class II	1981-07-20
K811983	Johnson & Johnson O.b. Tampons	Johnson & Johnson Professionals, Inc.	HEB	Class II	1981-07-20
K811964	Visitec Needle Range (Cardiovascular)	Visitec Co.	DRC	Class II	1981-07-20
K811961	Visitec Needle Range (Orthopaedic)	Visitec Co.			1981-07-20
K811933	Guardian, Volumetric Control Delivery	Avi, Inc.	FRN	Class II	1981-07-20
K811918	Amp Mark IV Infusion Pump	American Medical Products LLC	FRN	Class II	1981-07-20
K811910	Vein-Trap Tm	Atrium Medical Corporation	DWQ	Class II	1981-07-20
K811904	Century Hydro-San Therapy Tank	Century Manufacturing Co.	ILJ	Class II	1981-07-20
K811903	Century Hydrotherapy Pump	Century Manufacturing Co.	ILJ	Class II	1981-07-20
K811891	Norelco Massager Plus Heat Belt	North American Philips Corp.	ISA	Class I	1981-07-20
K811884	Ivac 700 Syringe Infusion Pump	Y	FRN	Class II	1981-07-20
K811834	Micro Oscillating Saw	Micro-Aire Surgical Instruments, Inc.	HSZ	Class I	1981-07-20
K811824	Cautery Caddy Pad	Instranetics, Inc.	KDC	Class I	1981-07-20
K811823	Sharps Caddy Fb	Instranetics, Inc.	KDC	Class I	1981-07-20
K811822	Tip-Vu	Instranetics, Inc.	KDC	Class I	1981-07-20
K811768	Coratomic Model Ovalith-920Bp	Corptomic	DXY	Class III	1981-07-20