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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 744 of 3530

510(k) clearances, page 744 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141341	Cl Detect Rapid Test	Inbios International, Inc.	PIT	Class I	2014-11-14
K141299	OTC Combo Tens/ems System	Well-Life Healthcare Limited	NUH	Class II	2014-11-14
K141076	Garment Electrodes	Shenzhen Dongdixin Technology Co., Ltd.	GXY	Class II	2014-11-14
K140438	Micro Guide Catheter Elite	Cordis Corp., A Johnson & Johnson Co.	PDU	Class II	2014-11-14
K140424	Respironics Reusable Heated Tubing	Respironics, Inc.	BZE	Class II	2014-11-14
K140078	Tecotherm Neo (T Neo)	Inspiration Healthcare, Ltd.	DWJ	Class II	2014-11-14
K133446	Heparin Lock / Flush Syringes	Excelsior Medical LLC	NZW	Class II	2014-11-14
K142658	Biomet Headless Compression and Twist-off Screws	Biomet Manufacturing Corp	HWC	Class II	2014-11-13
K142513	Barricade Embolization Coil System	Blockade Medical	HCG	Class II	2014-11-13
K142428	Shock Pulse-SE Lithotripsy System CYBERWAND II	Cybersonics, Inc.	FEO	Class II	2014-11-13
K142265	ONE Snare Endovascular Microsnare System	Merit Medical Systems, Inc.	MMX	Class II	2014-11-13
K142254	CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector	Abbott Medical	DQX	Class II	2014-11-13
K142219	GammaBeam 100	Best Theratronics Ltd.	IWB	Class II	2014-11-13
K142115	Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare Implant	Prismatik Dentalcraft, Inc.	NHA	Class II	2014-11-13
K142066	Aero-Ll Lumbar Cage System	Stryker Corp.	OVD	Class II	2014-11-13
K141989	Makoplasty Total Hip Allpication, Rio Standard System	Mako Surgical Corp.	OLO	Class II	2014-11-13
K141718	Internal Hydrating Gel	Combe Incorporated	NUC	Class II	2014-11-13
K141593	Unimicro Disposable Retrieval Endo-Pouch	Unimicro Medical Systems (Shenzhen) Co., Ltd.	GCJ	Class II	2014-11-13
K140492	Nexsite Hd (55Cm), Hemodialysis Catheter for Long Term Use	Marvao Medical Devices Ltd.	MSD	Class II	2014-11-13
K140466	Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300	St. Jude Medical Systems AB	DXO	Class II	2014-11-13
K140439	Omnipod Insulin Management System	Insulet Corporation	LZG	Class II	2014-11-13
K140352	Veraplug	Krishna Imports Inc dba Stephens Instruments	LZU	Unclassified	2014-11-13
K133896	Rejuvalite Md	Trophy Skin, Inc.	OHS	Class II	2014-11-13
K133643	Syngo, CT Liver Analysis	Siemens Medi Cal Solutions, Inc.	JAK	Class II	2014-11-13
K133175	Draeger Jaundice Meter Jm-105	Draeger Medical Systems, Inc.	MQM	Class I	2014-11-13
K132691	Abl90 Flex	Radiometer Medical ApS	MQM	Class I	2014-11-13
K143157	Coronis Fusion 4MP LED	Barco N.V.	PGY	Class II	2014-11-12
K143076	20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)	JVCKENWOOD Corporation	PGY	Class II	2014-11-12
K142903	neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US	Neosurgical, Ltd.	GCJ	Class II	2014-11-12
K142836	Zimmer Plates and Screws (ZPS), Forte Screws	Zimmer GmbH	HRS	Class II	2014-11-12
K142593	AngioVac Cannula	Boston Scientific Corporation	DWF	Class II	2014-11-12
K142301	Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath	Cook Vandergrift, Inc.	DRE	Class II	2014-11-12
K142047	Eidon	Centervue	MYC	Class II	2014-11-12
K141571	Orthofix Ankle Hindfoot Nailing System	Orthofix SRL	HSB	Class II	2014-11-12
K141457	Dentium Implantium and Superline Abutments	Dentium Co., Ltd.	NHA	Class II	2014-11-12
K141038	Ant Model 1	Advanced Nuclide Technologies, LLC	KXK	Class II	2014-11-12
K140934	Hiossen Implant System	Hiossen, Inc.	DZE	Class II	2014-11-12
K140807	Composite Orthodontic Brackets	Ortho Specialties	DYW	Class II	2014-11-12
K133929	Health Expert Elctronic Stimulator	Shenzhen Osto Technology Company Limited	NUH	Class II	2014-11-12
K141877	Leaf Patient Monitoring System	Leaf Healthcare, Inc.	KMI	Class I	2014-11-10
K141503	Denali 501Cement	Denali Corporation	EMA	Class II	2014-11-10
K140963	Kimguard Smart-Fold Sterilization Wrap	Kimberly-Clark Corporation	FRG	Class II	2014-11-10
K140961	Hoffmann Lrf (Limb Reconstruction Frame) System	Stryker Trauma GmbH	KTT	Class II	2014-11-10
K140951	Yeescope Laryngoscopes	Yeescope Pty., Ltd.	CCW	Class I	2014-11-10
K143001	Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing	Argentum Medical, LLC	FRO	Unclassified	2014-11-07
K142550	EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments	Microport Orthopedics Inc.	JWH	Class II	2014-11-07
K142215	Power Twin21-50/Power Twin21-100	Livetec GmbH	ILY	Class II	2014-11-07
K142139	Smr 40Mm Glenosphere	Lima Corporate S.p.A.	PHX	Class II	2014-11-07
K141990	Encore Humeral Shoulder Stem	Encore Medical, LP	PHX	Class II	2014-11-07
K141967	Purefill Oxygen Compressor	Inovo Inc.	CAW	Class II	2014-11-07