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 3347 of 3526

510(k) clearances, page 3347 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K801400	Disposable Sucker System	Texas Medical Products, Inc.	DTS	Class II	1980-06-30
K801399	Coronary Perfusion Connector Plug	Texas Medical Products, Inc.	DTL	Class II	1980-06-30
K801398	Aortic and Femoral Perfusion Cannulae	Texas Medical Products, Inc.	DWF	Class II	1980-06-30
K801397	Vena Cava Cannulae	Texas Medical Products, Inc.	DWF	Class II	1980-06-30
K801396	Saphenous Vein Cannulae	Texas Medical Products, Inc.	DWF	Class II	1980-06-30
K801395	Vascular Clamp	Texas Medical Products, Inc.	DXC	Class II	1980-06-30
K801394	Cardiopulmonary Bypass Pump Tubing	Texas Medical Products, Inc.	DWE	Class II	1980-06-30
K801393	Air Aspirator Needle	Texas Medical Products, Inc.	DWS	Class I	1980-06-30
K801392	Disposable Sump Sets	Texas Medical Products, Inc.	DWF	Class II	1980-06-30
K801363	Complement C3 Nephelometric Assay	J.T. Baker Chemical Co.	CZW	Class II	1980-06-30
K801361	Complement C4 Nephelometric Assay	J.T. Baker Chemical Co.	DBI	Class II	1980-06-30
K801353	Parke-Davis Surgical Light	Warner-Lambert Co.	FTD	Class II	1980-06-30
K801325	Clinical Audiometer Model Ta-200	Teledyne Avionics Div. of Teledyne	EWO	Class II	1980-06-30
K801322	Medi-Trace Disp. Lines for Physio. Press	Graphic Controls Corp.	DQO	Class II	1980-06-30
K801321	Package for Medi-Trace Physiological Pre	Graphic Controls Corp.	DQO	Class II	1980-06-30
K801297	Cobas Reagent for Glucose Rapid	Roche Analytical Instruments, Inc.	CFR	Class II	1980-06-30
K801296	Cobas Reagent for Cholesterol	Roche Analytical Instruments, Inc.	CHH	Class I	1980-06-30
K801290	Alizarin Sulfonate, Calcium	Union Carbide Corp.	CID	Class II	1980-06-30
K801289	Leeco Glyco-Hemoglobin Diag. Test Kit	Leeco Diagnostics, Inc.	LCP	Class II	1980-06-30
K801288	Emit Aaii Thyroxine Assay	Syva Co.	KLI	Class II	1980-06-30
K801287	Emit Aaii Thyroxine Calibrators	Syva Co.	JIS	Class II	1980-06-30
K801283	J.t. Baker Immuno. a Nephelometric Assay	J.T. Baker Chemical Co.	CZP	Class II	1980-06-30
K801282	J.t. Baker Immuno. M. Nephelometric Assa	J.T. Baker Chemical Co.	DFT	Class II	1980-06-30
K801241	Unipolar Programmable Lithium Card. Gen.	Arco Medical Products Co.	DXY	Class III	1980-06-30
K801197	CO2 Laser	Advanced Biomedical Instruments	HHR	Class II	1980-06-30
K801149	Bel O Sol Uva Sunlamp Device	Hopeful Sunlamp Corp.			1980-06-30
K801129	Quicktan Booth	Quicktan Mfg.			1980-06-30
K801122	Microthin-D1 (Mod. 0620)	Cardiac Pacemakers, Inc.	DXY	Class III	1980-06-30
K801121	Microthin-P1 (Mod. 0622)	Cardiac Pacemakers, Inc.	DXY	Class III	1980-06-30
K801076	Wako Phospholipids Test	Wako Pure Chemical Industries, Ltd.	CEL	Class I	1980-06-30
K801045	Gf120h Dialyzer	Gambro, Inc.	FJI	Class II	1980-06-30
K801040	Ge Lead Adapter, Model 345-01	Intermedics, Inc.	DTD	Class II	1980-06-30
K800837	Programmable Bipolar Cardiac Generator	Arco Medical Products Co.	DXY	Class III	1980-06-30
K800834	Ser-Tex	V.S.S.I., Inc.	KOH	Class I	1980-06-30
K800830	Siemens-Electrogerate Gmbh Micro-Inhaler	Macbeth Sales Corp.	CAF	Class II	1980-06-30
K800795	Permanent & Temp. Pacemaker Electrode	Daig Corp.	DTB	Class III	1980-06-30
K800789	Rubella Bio-Bead Titration Kit	Litton Bionetics	GOL	Class II	1980-06-30
K801436	Orthopedic Lower Extremity Suspension	Mizuho Orthopedic Systems Inc	FYH	Class I	1980-06-26
K801382	Disposable Surgical Head Support	Innovative Surgical Products, Inc.	FSE	Class I	1980-06-26
K801374	Proximate (Tmd) Tissue Measuring Device	Ethicon, Inc	FTY	Class I	1980-06-26
K801372	Argyle Vac-U-Care 100Cc Suct. Reservoir	Sherwood Medical Co.	GCY	Class I	1980-06-26
K801371	Argyle Vac-U-Care Flat Silicone Wound T.	Sherwood Medical Co.	GCY	Class I	1980-06-26
K801330	Anspach Leg Support	The Anspach Effort, Inc.	CCX	Class I	1980-06-26
K801326	Anspach Operating Table Support/spinal	The Anspach Effort, Inc.	EPW	Class I	1980-06-26
K801323	Hi-Temp Surgical Cautery	Medical Products Development, Inc.	GEI	Class II	1980-06-26
K801264	Nuclear Enterprises 1600/Gamma Counter	Nuclear Ent., Ltd.	JJJ	Class I	1980-06-26
K801243	Cobas Reagents for Uric Acid	Roche Analytical Instruments, Inc.	CDO	Class I	1980-06-26
K801224	Cambridge Cardiac Diagnostic System	Cambridge Instruments, Inc.	DXK	Class II	1980-06-26
K801222	Reagents for Astra 8 Automated Analyzer	Simmler Inc	JIX	Class II	1980-06-26
K801209	Kodak Medical X-Ray Developer & Replen.	Eastman Kodak Company	IXW	Class II	1980-06-26