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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 653 of 3529

510(k) clearances, page 653 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K161203	Soehendra Stent Retriever	Wilson-Cook Medical Inc.	FGE	Class II	2016-05-04
K160986	Xenco Medical Pedicle Screw System	Xenco Medical LLC	NKB	Class II	2016-05-04
K160936	Certus 140 2.45GHz Ablation System	Neuwave Medical, Inc.	NEY	Class II	2016-05-04
K160773	Yarlap II	International Trade Group, Inc.	KPI	Class II	2016-05-04
K160654	GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)	Medtronic, Inc.	KNT	Class II	2016-05-04
K160639	Electrosurgical Generator ESG-200	Olympus Winter & Ibe GmbH	GEI	Class II	2016-05-04
K160568	Precision Spine Interspinous Plate System	Precision Spine, Inc.	PEK	Class II	2016-05-04
K160503	Vented Vial Adapter Transfer Device - 13mm	West Pharma. Services IL, Ltd.	LHI	Class II	2016-05-04
K160006	Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit	Irvine Scientific LLC	MQL	Class II	2016-05-04
K153783	SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF	Spinevision Inc.	MAX	Class II	2016-05-04
K153277	6200 Ultrasound System and 6250 Ultrasound System	Esaote S.p.A.	IYN	Class II	2016-05-04
K160922	FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)	Agilent Technologies, Inc.	MXZ	Class II	2016-05-03
K160845	Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device	Boston Scientific Corporation	ODG	Class II	2016-05-03
K160118	STROPP (Single Tunnel Repair of Plantar Plate)	Crossroads Extremity Systems LLC	MBI	Class II	2016-05-03
K160084	Swan Ganz Catheters	Edwards Lifesciences LLC	DYG	Class II	2016-05-03
K160050	SERFAS 90-S Electrosurgical Probe	Stryker Corp.	GEI	Class II	2016-05-03
K153720	ENZA Zero-Profile Anterior Interbody Fusion	Camber Spine Technologies	OVD	Class II	2016-05-03
K152908	Ucp Compact Drug Tests	Ucp Biosciences, Inc.	DKZ	Class II	2016-05-03
K152029	Hamilton-H900, Hamilton-Bc8022, Hamilton-Bc4022, Hamilton-Bc8010, Hamilton-Bc4010	Hamilton Medical AG	BTT	Class II	2016-05-03
K160609	AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric	Alcon Laboratories	LPL	Class II	2016-05-02
K160357	Trinity	Koelis	IYN	Class II	2016-05-02
K160354	Mx50t(mx50tqs)	Wide Corporation	PGY	Class II	2016-05-02
K153745	Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider	Surgical Instrument Service and Savings Inc.(Dba Medline Ren	NUJ	Class II	2016-05-02
K153673	AirFit N20	ResMed Corp	BZD	Class II	2016-05-02
K153358	Standard Clamp	Standard Bariatrics	GDJ	Class I	2016-05-02
K152603	Green Laser Photocoagulator GYC-500	Nidek Co., Ltd.	HQF	Class II	2016-05-02
K152336	HEX tanning booth	J & B Products Ltd dba Hex Tanning	LEJ	Class II	2016-05-02
K151391	BTI Dental Implant System UnicCa	B.T.I. Biotechnology Institute, S.L.	DZE	Class II	2016-05-02
K151390	Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs	Maxter Glove Manufacturing Sdn Bhd	LZC	Class I	2016-05-02
K160960	EsophyX® Z Device with SerosaFuse Fasteners and Accessories	Endogastric Solutions, Inc.	ODE	Class II	2016-05-01
K160725	EndoFLIP	Crospon, Ltd.	FFX	Class II	2016-05-01
K160869	Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft	Cook Biotech Incorporated	FTM	Class II	2016-04-29
K160866	Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit	C.R. Bard Inc	DTK	Class II	2016-04-29
K160548	MC-Subtalar(TM) II	Merete GmbH	HWC	Class II	2016-04-29
K160304	OsteoBullet Compression Screw	Phalanx Innovations	HWC	Class II	2016-04-29
K160112	Besmed PEEP Valve	Besmed Health Business Corporation	BYE	Class II	2016-04-29
K160013	Crosperio OTW	KANEKA Corporation	LIT	Class II	2016-04-29
K160004	Crosstella OTW	KANEKA Corporation	LIT	Class II	2016-04-29
K153603	Alphatec Navigation Instruments	Alphatec Spine, Inc.	OLO	Class II	2016-04-29
K153168	Bi-Blade Vitrectomy Cutter	Medical Instrument Development Laboratories, Inc.	HQE	Class II	2016-04-29
K153064	Blue Sky Bio Zygomatic Implant System	Blue Sky Bio, LLC	DZE	Class II	2016-04-29
K153014	Mobius3D	Mobius Medical Systems, LP	IYE	Class II	2016-04-29
K152973	Dyna-Vision Telemonitoring System	Techmedic Development International B.V.	MHX	Class II	2016-04-29
K152903	REVIVAL(TM) Modular Revision Hip Stem	Corin USA	LZO	Class II	2016-04-29
K152892	da Vinci Xi Surgical System	Intuitive Surgical, Inc.	NAY	Class II	2016-04-29
K152619	Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)	Prosurg, Inc	GCJ	Class II	2016-04-29
K152552	Patient Monitor	Edan Instruments, Inc.	MHX	Class II	2016-04-29
K152412	T-32;T-40;T-44;T-52;T-72;Tt-50	Tanses Technologies, Inc.	LEJ	Class II	2016-04-29
K152299	TBS iNsight	Medimaps Group SA	KGI	Class II	2016-04-29
K152223	Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System	Oxyheal Medical Systems, Inc.	CBF	Class II	2016-04-29