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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2347 of 3531

510(k) clearances, page 2347 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K922969	King Diagnostics Urea Nitrogen Reagent	King Diagnostics, Inc.	CDN	Class II	1992-10-13
K922943	Nova Na/k/cl/li Module	Nova Biomedical Corporation	CEM	Class II	1992-10-13
K922926	Api Uniscept Kb/type 2 and 3	Analytical Products, Inc.	JWY	Class II	1992-10-13
K922690	Pain-Eez	International Center for Nutritional Research	GZJ	Class II	1992-10-13
K922352	The Advance Series from Hill-Rom	Hill-Rom Inc.	FNL	Class II	1992-10-13
K922299	Zeppelin Motor Drill System	Von Zeppelin Chirurgische Instrumente GmbH	HBE	Class II	1992-10-13
K922161	Grice Soft Tissue Biopsy Kit	Ideal Medical, Inc.	KNW	Class II	1992-10-13
K922157	Encore Ss-a	Trinity Biotech USA	LLL	Class II	1992-10-13
K922038	CO2 Insufflation Tubing	Surgeon Surgical Instrumentation, Inc.	HIF	Class II	1992-10-13
K921926	Jet Ventilator/jetting Device	Anesthesia Assoc., Inc.	BTL	Class II	1992-10-13
K921207	Drigel Defibrillator/synchronized Coardioversion	Physiometrix, Inc.	DRX	Class II	1992-10-13
K920622	Rascal II	GE Healthcare	CCK	Class II	1992-10-13
K920537	Subcutaneous Infusion Set	Marquette Medical, Inc.	FPA	Class II	1992-10-13
K920260	Intelect 600Mp	Chattanooga Group, Inc.	GZJ	Class II	1992-10-13
K914528	Safedwel(r) Central Venous Catheter	Becton Dickinson Vascular Access, Inc.	FOZ	Class II	1992-10-13
K913293	Quick Seeder	Mick Radio-Nuclear Instruments, Inc.	IWJ	Class I	1992-10-13
K913228	Interpore Imz Cylinder Implant System	Interpore Intl.	DZE	Class II	1992-10-13
K923676	Vista Thyroxine Uptake Assay	Syva Co.	KHQ	Class II	1992-10-09
K923615	Vista Hpq System	Philips North America LLC	LNH	Class II	1992-10-09
K923256	Alphatec 2.7 Mm Cannulated Cortical Lag Screw	Alphatec Spine, Inc.	HWC	Class II	1992-10-09
K922836	Chromophare	Berchtold Holding GmbH	FSY	Class II	1992-10-09
K922782	Spectrolyse/pl Pai Kit	Biopool AB	GGP	Class II	1992-10-09
K922274	Medrad Pathfinder-E Roadmapping System	Medrad, Inc.	JAA	Class II	1992-10-09
K921264	Surgiflator	Novanta Medical GmbH	HIF	Class II	1992-10-09
K921074	Bp Pump	Bio-Tek Instruments, Inc.	DXN	Class II	1992-10-09
K920641	Alcon Operating Microscopes	Alcon Laboratories	HRM	Class I	1992-10-09
K915790	Endo-Gard Electrosurgical Trocar	Conmedcorp	GCJ	Class II	1992-10-09
K915327	Elite II Electrocardiograph,modified	Siemens Burdick, Inc.	LOS		1992-10-09
K912815	Nibp 9225 Combi	S & W Medico Teknik	DXN	Class II	1992-10-09
K904070	Combison(r) 330, Model # Ir17.5ag/a & Vrw177ak/a	Kretztechnik AG	IYO	Class II	1992-10-09
K923545	Bard 7 Fr. Fiber Optic Assembly	C.R. Bard Inc	FGB	Class II	1992-10-08
K924165	Optisol-Gs Corneal Storage Media	Chiron Intraoptics	LYX	Unclassified	1992-10-06
K923974	Silimat Plus	Ivoclar North America, Inc.	EFD	Class I	1992-10-06
K923867	Metafil	Parkell, Inc.	EBF	Class II	1992-10-06
K923578	Liquichek Rheumatoid Factor Control	Bio-Rad	DHR	Class II	1992-10-06
K923480	Scimed Entre Ptca Guide Wire and Rendezvous Ptca	Scimed Life Systems, Inc.	DQO	Class II	1992-10-06
K923400	Dermco a-I	Dermaco, Inc.	KGX	Class I	1992-10-06
K923378	Usp Type VII Gauze Sponges	E.W.A., Ltd.	NAB	Class I	1992-10-06
K923355	Pharyngeal Salivary Bypass Tube	Boston Medical Products, Inc.	KCF	Class I	1992-10-06
K923352	Instrumentarium Mega4 Ht	Instrumentarium Imaging, Inc.	LNH	Class II	1992-10-06
K923116	Combine II Wetproof Pad	Hermitage Hospital Products, Inc.	NAB	Class I	1992-10-06
K922769	Sterile Surgeons Gloves -- Modification	Real Latex Pvt., Ltd.	KGO	Class I	1992-10-06
K922058	Models M1175a and M1176a Component Monitoring Syst	Hewlett-Packard Co.	MHX	Class II	1992-10-06
K922029	Remusk Mp	Equipement Biomedical Specialise, Inc.	LBB	Class II	1992-10-06
K921679	K-Disperse	Katecho LLC	GZJ	Class II	1992-10-06
K921300	Model Pc Argon Ion Laser	Hgm Medical Laser Systems, Inc.	GEX	Class II	1992-10-06
K921244	Disposable Protective Sheath	Cogentix Medical, Inc.	EOB	Class II	1992-10-06
K921002	Rondex Mask Models 9122/9111/9102/911102, Modified	Rondex Products, Inc.	BTM	Class II	1992-10-06
K920908	Over the Needle Splitable Catheter Assembly Type 1	Teleflexmedical, Inc.	DYB	Class II	1992-10-06
K920907	Over the Needle Splitable Catheter W/funnel Locato	Teleflexmedical, Inc.	DYB	Class II	1992-10-06