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 3387 of 3526

510(k) clearances, page 3387 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791888	Catheter Care Kit Reorder 7940&7941	Ascep, Inc.	EFQ	Unclassified	1979-10-17
K791887	Central Venous Catheter Dressing Tray	Ascep, Inc.	FSM	Class I	1979-10-17
K791874	Calcium/phosphorus/magnesium Standard	Gilford Diagnostics	JIX	Class II	1979-10-17
K791864	Instrument Pad	Procter & Gamble Mfg. Co.	KKX	Class II	1979-10-17
K791855	Centria Tsh Ria	Union Carbide Corp.	JLW	Class II	1979-10-17
K791845	Bayonet Heifetz Clip Appliers	Edward Weck, Inc.	GDO	Class I	1979-10-17
K791824	Antiserum to Human Immunoglobulins	Icl Scientific	DEW	Class II	1979-10-17
K791770	Quantimune Gentamicin Ria Gentamicin	Bio-Rad	DJB	Class II	1979-10-17
K791749	Indirect Immuno Enzyme,antigen,control	Clinical Sciences, Inc.	DAA	Class II	1979-10-17
K791725	Cholinesterase Reagent	Gilford Diagnostics	DIH	Class I	1979-10-17
K791724	Bio-Bag Environmental Chamber (a & B)	Marion Laboratories, Inc.	JTX	Class I	1979-10-17
K791711	Improved Gram Stain Reagents	Carr-Scarborough Microbiologicals, Inc.	HYI	Class I	1979-10-17
K791707	Centria Insulin Ria	Ventrex Laboratories, Inc.	CFP	Class I	1979-10-17
K791706	Be-Sure	Precision Products Corp.	JHJ	Class II	1979-10-17
K791658	Wright Stain Pack	Bioscientific			1979-10-17
K791642	A-Gent Glycospec	Abbott Medical	LCP	Class II	1979-10-17
K791596	Fluoromatic Tobramycin Fia Immunoassay	Bio-Rad	KLB	Class II	1979-10-17
K791551	Hi-M-Test Morphine	Technam, Inc.	DLR	Class II	1979-10-17
K791414	Dtm (Dermatophyte Test Medium) Agar	Biomedia, Inc.	JSI	Class I	1979-10-17
K791413	Culture and Sensitivity Kit	Biomedia, Inc.	JTZ	Class II	1979-10-17
K791404	Lancer L-Ina Anti-C3	Sherwood Medical Co.	CZW	Class II	1979-10-17
K791403	Lancer L-Ina Anti-Igg	Sherwood Medical Co.	DEW	Class II	1979-10-17
K791402	Lancer L-Ina Anti-Igm	Sherwood Medical Co.	DFT	Class II	1979-10-17
K791401	Lancer L-Ina Anti-Iga	Sherwood Medical Co.	CZP	Class II	1979-10-17
K791326	Monoject Endosseous Dental Implant Tool	Sherwood Medical Co.	DZI	Class II	1979-10-17
K791285	Anti-Human Globulins	Diagnostica, Inc.	DEW	Class II	1979-10-17
K791282	Anti-Human Serum	Diagnostica, Inc.	DGQ	Class I	1979-10-17
K791547	Fluoromatic Gentamicin Fia Immunoassay	Bio-Rad	DJB	Class II	1979-10-12
K791087	Portable Pulse Galvanic Stimulator	Staodynamics, Inc.	IPF	Class II	1979-10-12
K790792	Pulse Generator Model 637	Elema-Schonander, Inc.	DXY	Class III	1979-10-12
K791972	Argyle Pediatric Vena Caval Catheter	Sherwood Medical Co.	DWF	Class II	1979-10-11
K791964	Model 15055A Mainframe	Hewlett-Packard Co.	DRR	Class II	1979-10-11
K791957	Seracon -Lo Do26	Bhp Diagnostix, Inc.	JJX	Class I	1979-10-11
K791956	Seracon Cal D025	Bhp Diagnostix, Inc.	JIX	Class II	1979-10-11
K791929	Wrights Rapid Stain	Mcb Manufacturing Chemists, Inc.	IAF	Class I	1979-10-11
K791914	3-Way Stopcock W/male Locking Luer Ada.	Abbott Medical	DTL	Class II	1979-10-11
K791900	M015 Oxygen & Ma15 Air	Timeter Instrument Corp.	CAX	Class I	1979-10-11
K791797	Mts Catheter Adapter for Guidance Entry	Medical Testing System, Inc.	DTL	Class II	1979-10-11
K791791	Ortho Antibody Enhancement Solution	Ortho Diagnostics, Inc.	KSG	Class II	1979-10-11
K791772	Counter-Check Plus Normal, High Abn.	Diagnostic Technology, Inc.	JPK	Class II	1979-10-11
K791767	Bovie Csv Hand Control Adapter	Sybron Corp.	GEI	Class II	1979-10-11
K791750	Counter-Check Plus	Diagnostic Technology, Inc.	JPK	Class II	1979-10-11
K791697	Cdc Anaerobic Blood Agar Phenethylal	Gibco Laboratories Life Technologies, Inc.	JSJ	Class I	1979-10-11
K791659	Meditec (Rodenstock) Laser Photocoagul	Coburn Optical Ind., Inc.	HQF	Class II	1979-10-11
K791649	Tetrahydrocannalbinol Direct Blood Kit	Immunalysis Corporation	LAT	Class II	1979-10-11
K791513	Adamco Dust Cover	Chase Mfg. Co.	FRG	Class II	1979-10-11
K791431	Technicon Fast-Lc Sys. for Theophylline	Technicon Instruments Corp.	DPA	Class I	1979-10-11
K791415	Model 80-1765 Electrosurgical Unit	Cameron-Miller, Inc.	GEI	Class II	1979-10-11
K791399	Acu-Alert	Acumed Instruments Corp.			1979-10-11
K791375	Autopak 12 T3 Ria Test Delivery System	Micromedic Systems	CDP	Class II	1979-10-11