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 1887 of 3531

510(k) clearances, page 1887 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K970414	Confocal Microscope	Con-S, Ltd.	HJO	Class II	1997-07-15
K970160	Uniject Surgical Gloves	Uniject Gloves, Ltd.	KGO	Class I	1997-07-15
K965068	Magnetic Resonanc Dvce Visart V 3.5 Software	Toshiba America Medical Systems, In.C	LNH	Class II	1997-07-15
K964646	Video Eye Trakker	Micromedical Technologies, Inc.	GWN	Class II	1997-07-15
K964325	Visualeyes: Video Eye Monitor	Micromedical Technologies, Inc.	GWN	Class II	1997-07-15
K972362	Fovs, Brillarte, Etc...	Sunglass City, Inc.	HQY	Class I	1997-07-14
K972330	Innofluor Phenobarbital Assay System	Oxis Intl., Inc.	LGQ	Class II	1997-07-14
K972288	Factor Deficient Plasmas - Factor IX (9)	Universal Reagents, Inc.	GGP	Class II	1997-07-14
K972286	Factor Deficient Plasmas - Factor XI (11)	Universal Reagents, Inc.	GJT	Class II	1997-07-14
K972190	Thyroglobulin Assay System	American Laboratory Products Company	JZO	Class II	1997-07-14
K971945	Pure Advantage Powder Free Nitrile Hypoallergenic Surgical Glove	Tillotson Healthcare Corp.	KGO	Class I	1997-07-14
K971926	Quikstrip One Step Cocaine Test	Drial Consultants, Inc.	DIO	Class II	1997-07-14
K971795	Automated Chamber Maintenance Module	Paradigm Medical Industries, Inc.	HQC	Class II	1997-07-14
K971776	Echovacs	Vmi Technologies	LLZ	Class II	1997-07-14
K971697	Etest for Levofloxacin	Ab Biodisk	JWY	Class II	1997-07-14
K971675	Snt Stereotactic Localization System	Surgical Navigation Technologies, Inc.	HAW	Class II	1997-07-14
K971646	4F Nylex Angiography Catheter/5f Nylex Angiography Catheter	Cordis US Corp.	DQO	Class II	1997-07-14
K971618	Alcon Contact Lens Case	Alcon Laboratories	LRX	Class II	1997-07-14
K971572	Vista Brite Tip Catheters	Cordis US Corp.	DQY	Class II	1997-07-14
K971566	Creatine Kinase-Mb Reagent Set	Horizon Diagnostics, Inc.	CGS	Class II	1997-07-14
K971561	Provest-Protective Restraint	Jemm Medical Products	FMQ	Class I	1997-07-14
K971538	Mentor Gemini Hemostatic Eraser	Mentor Ophthalmics, Inc.	HQO	Class II	1997-07-14
K971474	Medtronic Model 5318 Temporary Pacemaker/implant Tool	Medtronic, Inc.	DTE	Class II	1997-07-14
K971395	Guglielmi Detachable Coil (Gdc), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce	Target Therapeutics	DQX	Class II	1997-07-14
K971393	Mycoplasma Igg Elisa Test System	Immunoprobe, Inc.	LJZ	Class I	1997-07-14
K971385	Sunglasses	Kosway Industries Co., Ltd.	HQY	Class I	1997-07-14
K971306	Fg Infusion Catheter	Cordis Neurovascular, Inc.	KRA	Class II	1997-07-14
K970819	Targobeam	Ferguson Medical	JAK	Class II	1997-07-14
K970770	Latex Examination Gloves	Oon Corp. Resources	LYY	Class I	1997-07-14
K970763	Modular Telemetry System (Mts) Option for the Mde Escort II Monitor	Medical Data Electronics	DQA	Class II	1997-07-14
K970546	Acs Digitoxin	Chiron Diagnostics Corp.	LFM	Class II	1997-07-14
K965130	Chromophare	Berchtold Holding GmbH	FSY	Class II	1997-07-14
K965128	Cynosure Photogenica Vlv Cutaneous Vascular Lesion Laser	Cynosure, LLC	GEX	Class II	1997-07-14
K965100	N-Assay Tia Alpha-1-Antitrypsin Test Kit	Crestat Diagnostics, Inc.	DEM	Class II	1997-07-14
K965024	N-Assay Tia C1-Inactivator Test Kit	Crestat Diagnostics, Inc.	DBA	Class II	1997-07-14
K964301	N-Assay Tia Multi V-Nl	Crestat Diagnostics, Inc.	DAD	Class II	1997-07-14
K964300	N-Assay Tia Multi V-Nl	Crestat Diagnostics, Inc.	DBI	Class II	1997-07-14
K964299	N-Assay Tia Multi V-Nl	Crestat Diagnostics, Inc.	LKL	Class I	1997-07-14
K964298	N-Assay Tia Multi V-Nl	Crestat Diagnostics, Inc.	CZW	Class II	1997-07-14
K964297	N-Assay Tia C4 Test Kit	Crestat Diagnostics, Inc.	DBI	Class II	1997-07-14
K963789	Dtx-100 Bone Densitometer	Osteometer Meditech A/S	KGI	Class II	1997-07-14
K963565	MRI Needles	Cook Inc.	FCG	Class II	1997-07-14
K963208	Nervepace(r) Nerve Conduction Viewscope (200Vs)	Neurotron Medical	JXE	Class II	1997-07-14
K962539	Gantex Model Nsg-75Pf	American Pro Latex, Inc.	KGO	Class I	1997-07-14
K960974	Cobe Century Perfusion Pump	LivaNova USA, Inc.	DWB	Class II	1997-07-14
K951459	Ortho-Mune Okt 4A (Cd4) - Monoclonal Antibody (Murine) Fitc Conjugate	Ortho Diagnostic Systems, Inc.	GKZ	Class II	1997-07-14
K971988	Allen, Ultra and Smart Sockets	Allen Medical Systems, Inc.	FQO	Class I	1997-07-11
K971105	Myotherm (Tm) Xp Cardioplegia Delivery System	Avecor Cardiovascular, Inc.	DTN	Class II	1997-07-11
K970461	Cell Robotics Er: Yag Surgical Laser	Cell Robotics, Inc.	GEX	Class II	1997-07-11
K972259	Pro Check Digital Pacifier Thermometer	Micro Weiss Electronics	FLL	Class II	1997-07-10