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 944 of 3531

510(k) clearances, page 944 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101769	Episil	Camurus AB	OLR	Unclassified	2011-09-13
K112400	Smartshears	Nuscience Consulting and Management Group, LLC	FZT	Class I	2011-09-12
K111724	Straumann Tibrush	Straumann USA, LLC	ELB	Class II	2011-09-12
K111484	Discovery	Intuitive Spine, LLC	ODP	Class II	2011-09-12
K111438	Reka E100	Reka Pte, Ltd.	DPS	Class II	2011-09-12
K111390	Sfi-Bar (R) Implant Adapter Spi (R) Element Pf 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, Sfi-Bar (R) Implant Adapter Stra..	Cendres & Metaux SA	NHA	Class II	2011-09-12
K111178	Juell Soft Cure	Juell Dental	EBI	Class II	2011-09-12
K111177	Juell Hard Cure	Juell Dental	EBI	Class II	2011-09-12
K110713	Waterpap Valve	Airways Development, LLC	BYE	Class II	2011-09-12
K112395	Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants Urine Test	Guangzhou Wondfo Biotech Co., Ltd.	LFG	Class II	2011-09-09
K112327	Sensation(tm) Plus 8Fr. 50Cc Intra-Aortic Balloon Catheter and Accessories	Cardiac Assist, Maquet Cardiovascular, LLC	DSP	Class II	2011-09-09
K112313	Toshiba 3T Extra Large Knee Coil	Quality Electrodynamics	MOS	Class II	2011-09-09
K111887	Closurefast Radiofrequency Catheter	Medtronic, Inc.	GEI	Class II	2011-09-09
K111759	.Decimal Electron Aperture	.Decimal, Inc.	IXI	Class II	2011-09-09
K111704	Avinger Wildcat 6F Guidewire Support Catheter and Juicebox	Avinger, Inc.	DQY	Class II	2011-09-09
K111635	Smith & Nephew Rj Constrained Liners	Smith & Nephew, Inc.	KWZ	Class II	2011-09-09
K111626	Endoskeleton(r) Tas	Titan Spine, LLC	OVD	Class II	2011-09-09
K111622	Unimax Anti-Fog Solution	Unimax Medical Systems Inc.	OCT	Class II	2011-09-09
K111346	Resolutionmd Mobile Model Rmb-Mob-2X	Calgary Scientific, Inc.	LLZ	Class II	2011-09-09
K111285	Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with Cutting	Salient Surgical Technologies, Inc.	GEI	Class II	2011-09-09
K111116	Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000	GE Healthcare	CBK	Class II	2011-09-09
K111060	Mrgfus Pelvic Pa Coil Model 1.0	Insightech, Ltd.	MOS	Class II	2011-09-09
K110754	Cryopen Cryosurgical System, K102214	Cryopen, Inc.	GEH	Class II	2011-09-09
K110086	Ifs Profile Plates, Screws, and Washers	Internal Fixation Systems, Inc.	HRS	Class II	2011-09-09
K103489	Ge Veo Reconstruction Option	General Electric Co.	JAK	Class II	2011-09-09
K102633	Bioteq Angiographic Catheter	Bioteque Corp.	DQO	Class II	2011-09-09
K101986	Asahi Ultimatebros 3 Ptca Guide Wire	Asahi Intecc Co., Ltd.	DQX	Class II	2011-09-09
K112386	Exair Anterior and Posterior Prolapse Repair System	MEDLINE INDUSTRIES, LP - Northfield	OTP	Class III	2011-09-08
K112329	Omni Patient Monitor	Infinium Medical, Inc	MWI	Class II	2011-09-08
K112310	Wondfo Methadone Urine Test,opiate Test	Guangzhou Wondfo Biotech Co., Ltd.	DJG	Class II	2011-09-08
K112209	Prefilled Catheter Inflation Syringe	Avail Medical Products, Inc.	KNY	Class II	2011-09-08
K111802	Sv Brain Array, Siemens 3T	Mri Interventions, Inc.	MOS	Class II	2011-09-08
K111613	Xelis Fusion	Infinitt Co., Ltd.	LLZ	Class II	2011-09-08
K111577	Medline Vial Decanter	MEDLINE INDUSTRIES, LP - Northfield	LHI	Class II	2011-09-08
K111505	Rtvue Cam with Corneal Power Upgrade	Optovue Inc.	OBO	Class II	2011-09-08
K111462	Fixate Tissue Band	Anulex Technologies, Inc.	GZB	Class II	2011-09-08
K111166	A-Wedge Anterior Interbody System (a-Wedge A.i.s.)	Spineworks, LLC	MAX	Class II	2011-09-08
K110818	Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein Tests	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	CIX	Class II	2011-09-08
K110403	Prolink Adhesives (Prolink, Prolink Se)	Silmet Ltd.	KLE	Class II	2011-09-08
K103615	Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic Phosphorus u.v. Reagent,urine Standard	Alfa Wassermann Diagnostic Technologies, Inc.	CDN	Class II	2011-09-08
K103132	Freshkonalluring Eyes, Freshkon Colors Fusion, Freshkoncolors Fusion Sparklers, Freshkon Mosaic, Freshkon Glitzi	Oculus Private Limited	LPL	Class II	2011-09-08
K112399	Unite Biomatrix	Synovis Orthopedic & Woundcare	KGN	Unclassified	2011-09-07
K112272	Em44 Self Monitoring Blood Glucose System, Em44 Pro Self Monitoring Blood Glucose System	Eps Bio Technology Corp.	LFR	Class II	2011-09-07
K111729	Pilot Spinal System	Life Spine	NKB	Class II	2011-09-07
K111696	Opal Band Cement	Ultradent Products Inc.	DYH	Class II	2011-09-07
K111666	Evadyne Temporary Crown and Bridge Resin	Neodental Chemical Products Co., Ltd.	EBG	Class II	2011-09-07
K110637	Onetouch Verio (Tm) Iq Blood Glucose Monitoring System	Cilag GmbH International	LFR	Class II	2011-09-07
K102944	Coreleader Hemo-Pad Model Cpii 02030	Coreleader Biotech Co., Ltd	QSY	Unclassified	2011-09-07
K112324	Ceralas 980Nm Diode Laser Family	Biolitec Medical Devices, Inc.	GEX	Class II	2011-09-06
K112245	Xtra	Corcym Inc.	CAC	Class II	2011-09-06