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 3326 of 3528

510(k) clearances, page 3326 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802682	Contact Seal	Vivadent (USA), Inc.	EBC	Class II	1980-11-24
K802681	Heliobond	Vivadent (USA), Inc.	KLE	Class II	1980-11-24
K802672	Cardioactive Drugs Control	Fisher Scientific Company L.L.C.	DIF	Class I	1980-11-24
K802668	Cybrex Tobramycin	Abbott Medical	LCR	Class II	1980-11-24
K802660	Answer at-Home Pregnancy Test Kit	Armkel, LLC	JHJ	Class II	1980-11-24
K802653	Medium Size Oxygen Hood #1547	Ann Arbor Plastics, Inc.	BYL	Class I	1980-11-24
K802573	Serum T4 by Enzyme Immunoassay	Worthington Diagnostic Systems	CDX	Class II	1980-11-24
K802374	Robertson Obturation Monitor Insuffla	Endotek Corp.	FAP	Class II	1980-11-24
K802278	In Vitro Diagnostic Standards	Supelco, Inc.	DIF	Class I	1980-11-24
K802037	Vitamin B12 Folate Radioassay	Corning Medical & Scientific	CCN	Class I	1980-11-21
K802288	Swan Ganz Catheter Placement Kit	Stanco Medical, Inc.	DYG	Class II	1980-11-20
K802287	Right Atrial Line Kit	Stanco Medical, Inc.	DQY	Class II	1980-11-20
K802803	Convalescent Recliner	Winfield Co., Inc.	INO	Class II	1980-11-19
K802782	The Criterion II Pacing Sys. Monitor	Dart Medical Equipment	DRT	Class II	1980-11-19
K802776	Hoffman Leg Lengthening Device	Howmedica Corp.	JEC	Class II	1980-11-19
K802761	Latex Penrose Tubing Cat. #20400,414,416	American Hospital Supply	GAZ	Class II	1980-11-19
K802745	Folding Shower-Commode Chair	Winco Winfield Co., Inc.	INM	Class I	1980-11-19
K802744	Folding Roll-About Chair	Winco Winfield Co., Inc.	INM	Class I	1980-11-19
K802726	Instruments Nonsterile & Sterile	Ascep, Inc.	HAO	Class I	1980-11-19
K802723	Extended Balljoint Grip	Howmedica Corp.	JEC	Class II	1980-11-19
K802722	External Fixation System	Howmedica Corp.	JEC	Class II	1980-11-19
K802713	Fms-02 Floor-Unit Model Microscope	JEDMED Instrument Company	FSO	Class I	1980-11-19
K802675	Endotracheal Tube Holder	Respiratory Support Products, Inc.	JAY	Class I	1980-11-19
K802607	Terperatur Sensing Device	Burditt & Calkins-Siemens-Elema	FLL	Class II	1980-11-19
K802598	Carbide Cutting Instrument/intraarticu	The Anspach Effort, Inc.	HTT	Class I	1980-11-19
K802588	Model 3003 Unipolar Demand Cardiac Gen.	Arco Medical Products Co.	DXY	Class III	1980-11-19
K802490	Reigning Denture	Oki Shiks USA, Ltd.	EBI	Class II	1980-11-19
K802476	Cardiacindex Computer Model Sp 1435	Gould, Inc.	DXG	Class II	1980-11-19
K802460	Helfet Elbow Prosthesis	Depuy, Inc.	JDB	Class II	1980-11-19
K802249	Microlet Family of Needle/depth Elect-	Progress Mankind Technology	GZL	Class II	1980-11-19
K802221	Chronocor IV Model 250	Cordis US Corp.	DTE	Class II	1980-11-19
K802152	Pmt Depthalon Depth #2102	Progress Mankind Technology	GZL	Class II	1980-11-19
K802151	Pmt Depthalon Depth Corticography Elec	Progress Mankind Technology	GZL	Class II	1980-11-19
K802058	Mapping Probe Model #6540	Cardiac Pacemakers, Inc.	DRF	Class II	1980-11-19
K801947	CPR Traveler	Cardia Concepts Corp.	DRM	Class II	1980-11-19
K801946	CPR Helper	Cardia Concepts Corp.	DRM	Class II	1980-11-19
K801945	Save Mor	Cardia Concepts Corp.	DRM	Class II	1980-11-19
K792609	Lithicron 0520 P-Synchroneous Pulse Gen.	Medcor, Inc.	DXY	Class III	1980-11-19
K801890	Ic-2 Ventilator	Bio-Med Devices, Inc.	CBK	Class II	1980-11-18
K801623	Cavitron Ultrasonic Surg. Aspir. Cusa	Cavitron Corp.	LFL	Unclassified	1980-11-18
K802866	Sharps Caddy Magnetic & Sharps Caddy Foa	Instranetics, Inc.	KDC	Class I	1980-11-17
K802570	A.m.p.c.o. Skin Scrub Tray	Associated Medical Products Co.	FSM	Class I	1980-11-14
K801927	Silentsleep	Slumber Research, Inc.	DYN	Class I	1980-11-14
K801934	Worrell Patella Femoral Shield	Depuy, Inc.			1980-11-13
K800870	Medtronic Model 6958	Medtronic, Inc.	DTB	Class III	1980-11-13
K802751	P-10 Posterior Filling Material	3M Company	EBH	Class I	1980-11-12
K802716	Den-Mat Fiber Optic Halogen Light	Den-Mat Corp.	EAY	Class I	1980-11-12
K802710	Infant Apnea Monitor	Douglas Scientific Products	FLS	Class II	1980-11-12
K802707	Drager PEEP Control System	Draeger, Inc.	BYE	Class II	1980-11-12
K802703	Liquid Chromatography Columns	Supelco, Inc.	DPM	Class I	1980-11-12