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 2026-11-02, 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 2534 of 3531

510(k) clearances, page 2534 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K901691	Cvis Insight 15Mhz Catheters for Peripheral Use	Cardiovascular Imaging Systems, Inc.	DQO	Class II	1990-07-06
K901672	Resubmitted Water Purifier for Use W/dental Treat	KaVo Dental Technologies, LLC	EIA	Class I	1990-07-06
K901628	Applied Vascular Devices 6Mm Traction Clip	Applied Vascular Devices, Inc.	DXC	Class II	1990-07-06
K901625	Fogarty Arterial Embolectomy II Catheter	Baxter Healthcare Corporation	DXE	Class II	1990-07-06
K901601	Hollow Motor Drive Unit	Devices for Vascular Intervention, Inc.	LIT	Class II	1990-07-06
K901074	Code #94315 Retrograde Coronary Sinus Perf Cannula	Dlp, Inc.	DWF	Class II	1990-07-06
K901063	Luer Lock Transfer Pin	Acacia, Inc.	LHI	Class II	1990-07-06
K896883	Gc Cervical Cement	G-C Intl. Corp.	EMA	Class II	1990-07-06
K895695	Bird Microblender m.r.i.	Bird Products Corp.	BZR	Class II	1990-07-06
K895145	Second Generation Knee System, Femoral, Patellar	Orthomet, Inc.	JWH	Class II	1990-07-06
K902385	Sunshades, Acrylic Lenses, Order #Sg-01	Tel-Time Products	HQY	Class I	1990-07-05
K902333	Opus Tsh Test System	Pb Diagnostic Systems, Inc.	JLW	Class II	1990-07-05
K902322	Solar-Mates Sunglasses, Bonjour Eyewear	Nevitt Sales Corp.	HQY	Class I	1990-07-05
K902243	Technicon Immuno I(tm) System and Analytes	Technicon Instruments Corp.	KLS	Class II	1990-07-05
K902150	Piezo Handpiece	United Surgical LLC	HQC	Class II	1990-07-05
K902138	Stripe Projector	Academic Catalyst Corp.	HJI	Class I	1990-07-05
K901945	Sunglasses - Impact Resistant Lenses (Acrylic)	Zebco Corp.	HQY	Class I	1990-07-05
K901839	60 Fundus Camera Cf-60Uv	Canon Medical Components U.S.A., Inc.	HJI	Class I	1990-07-05
K900944	Sunglasses	K Mart Apparel Corp.	HQY	Class I	1990-07-05
K900788	Modified Apsara Clinical Diagnostic Analyzer	Datachem, Inc.	CEM	Class II	1990-07-05
K900531	Nonabsorbable Nylon Surgical Suture*	United States Surgical, A Division of Tyco Healthc	GAR	Class II	1990-07-05
K900198	Dexon II Absorbable Surgical Suture, U.s.p.	American Cyanamid Co.	GAN	Class II	1990-07-05
K895579	Polysorb Synthetic Absorbable Suture	United States Surgical, A Division of Tyco Healthc	GAN	Class II	1990-07-05
K902565	Aladan Tri-Clean 110 Powderless Latex Glove	Aladan Corp.	LYY	Class I	1990-07-03
K902517	Neurosurgical Headframe Accessories	Sims Surgical, Inc.	GZT	Class II	1990-07-03
K902516	New Length Sugita Appliers	Sims Surgical, Inc.	HIC	Class II	1990-07-03
K902294	Accuscan Microbead Standards	Sigma Chemical Co.	JIW	Class II	1990-07-03
K902210	Orthokrome Normal and Abnormal Control Plasma	Ortho Diagnostic Systems, Inc.	GGN	Class II	1990-07-03
K902134	Minix, Minix St, New Ic: L74	Medtronic, Inc.	DXY	Class III	1990-07-03
K902096	Thromboplastin with Calcium	Sigma Chemical Co.	GJS	Class II	1990-07-03
K902081	Clottrac(tm) Ibex Heparinase Hr Act Cart./control	Hemotec, Inc.	JBP	Class II	1990-07-03
K901936	Plus Total Knee Syst/peri Post Design Tibial Comp	Orthomet, Inc.	JWH	Class II	1990-07-03
K901815	Modified Sterilization of Intra-Art(tm) Coronary	Pioneering Technologies, Inc.	DRE	Class II	1990-07-03
K901770	Challenge 7000 Powered Muscle Stimulator	Maximum Performance Technologies, Mpts, Inc.	IPF	Class II	1990-07-03
K901769	Challenge 6000 Powered Muscle Stimulator	Maximum Performance Technologies, Mpts, Inc.	IPF	Class II	1990-07-03
K901768	Challenge 5000 Powered Muscle Stimulator	Maximum Performance Technologies, Mpts, Inc.	IPF	Class II	1990-07-03
K901744	Dobbhoff(r) Retrieval Forceps	Biosearch Medical Products, Inc.	KQW	Class I	1990-07-03
K901737	Sonoca II Ultrasonic Surgical Device	Holl Meditronics, Inc.	LFL	Unclassified	1990-07-03
K901722	Chemosite(tm) Implantable Drug Delivery System	Device Labs, Inc.	LJT	Class II	1990-07-03
K901721	Modified Target Therapeutics Coils	Target Therapeutics	HCG	Class II	1990-07-03
K901682	Pti Anastomark(tm) Coronary Bypass Graft Markers	Pioneering Technologies, Inc.	DSY	Class II	1990-07-03
K901670	Gnomos Stereotactic Device	Medical Equipment Development Co., Inc.	HAW	Class II	1990-07-03
K901624	Shiley Plexus Integral Reservoir Hollow Fiber Oxy.	Shiley, Inc.	DTZ	Class II	1990-07-03
K901558	Giotto Mammography HF	Medical Device Marketing Network, Inc.	IZH	Class II	1990-07-03
K901535	Modified Medtronic Classix Model 8438 Pulse Gene.	Medtronic, Inc.	DXY	Class III	1990-07-03
K900771	Attest Brand Rapid Readout Biological Indicator	3M Company	FRC	Class II	1990-07-03
K900587	Sempermed Surgeon's Gloves	Semperit Industrial Products	KGO	Class I	1990-07-03
K900443	Burns Casualty Sheet Limb Wrap	Pilgrim Medical Services	FPY	Class I	1990-07-03
K900442	Burns Casualty Sheet Burn Roll	Pilgrim Medical Services	FPY	Class I	1990-07-03
K900441	Burns Casualty Sheet	Pilgrim Medical Services	FPY	Class I	1990-07-03