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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 395 of 3528

510(k) clearances, page 395 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K201079	Aurora® Anterior Lumbar Plate Sytstem	Prism Surgical Design Pty, Ltd.	KWQ	Class II	2020-08-05
K200977	Modular Toga	Operating Room Innovations, Inc	FYA	Class II	2020-08-05
K200780	XBit Series Digital Color Doppler Ultrasound System	CHISON Medical Technologies Co., Ltd.	IYN	Class II	2020-08-05
K200351	PlasmaFlight	Manamed LLC	IRP	Class II	2020-08-05
K200009	Adaptive Biotechnologies clonoSEQ Assay	Adaptive Biotechnologies	QDC	Class II	2020-08-05
K193247	LATITUDE EV™ Total Elbow Arthroplasty	TORNIER Inc.	JDB	Class II	2020-08-05
K192883	Spartan Hip Stem	Signature Orthopaedics Pty Limited	LZO	Class II	2020-08-05
K191955	Enhanced External Counter Pulsation Device Plus Omay-A	Omay(guangzhou) Med Technologies Co., Ltd	DRN	Class II	2020-08-05
K190580	NADIA SI Fusion System	Ilion Medical Inc	OUR	Class II	2020-08-05
K201958	ETD Family of Electrotherapy Devices	Therasigma, LLC	IPF	Class II	2020-08-04
K201850	Vector Hammertoe Correction System	Nvision Biomedical Technologies, Inc	HWC	Class II	2020-08-04
K201704	CoFix System	Paradigm Spine GmbH	PEK	Class II	2020-08-04
K201500	Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer	Life Spine	MAX	Class II	2020-08-04
K201217	HemoCue Hb 301 System	HemoCue AB	GKR	Class II	2020-08-04
K201168	ECG Monitor App	Samsung Electronics Co., Ltd.	QDA	Class II	2020-08-04
K193666	Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff	MEDLINE INDUSTRIES, LP - Northfield	LZA	Class I	2020-08-04
K193545	Corin Optimized Positioning System (OPS) Femoral	Corin USA	LZO	Class II	2020-08-04
K193210	Hyper Dlr	Shanghai United Imaging Healthcare Co., Ltd.	KPS	Class II	2020-08-04
K191670	CureOs TCP	Linacol Muh Dan Kim Cev Tek Med Ith Ihr San ve Tic	MQV	Class II	2020-08-04
K200954	Glaucoma Module	Topcon Healthcare Solutions	NFJ	Class II	2020-08-03
K200667	EyeArt	Eyenuk	PIB	Class II	2020-08-03
K200649	Arm-Type Fully Automatic Digital Blood Pressure Monitor	Joytech Healthcare Co., Ltd.	DXN	Class II	2020-08-03
K193355	Electrodes Handpieces for Mygen V-1000 RF System	RF Medical Co., Ltd	GEI	Class II	2020-08-03
K192991	Vesco Medical Extension Feeding Set	Vesco Medical LLC	PIF	Class II	2020-08-03
K192712	Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter	Medtronic, Inc.	DQY	Class II	2020-08-03
K201951	Cemented Origin Hip Stem	Signature Orthopaedics Pty Limited	LZO	Class II	2020-07-31
K201898	Clear Guide SCENERGY	Clear Guide Medical	JAK	Class II	2020-07-31
K201837	UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge	Neotract Inc	PEW	Class II	2020-07-31
K201833	BiPad Hand Activated, Disposable Bipolar Electrocautery Cords	Bipad Surgical, Inc.	GEI	Class II	2020-07-31
K201597	Liver Incytes, Model 1005	Sonic Incytes	IYO	Class II	2020-07-31
K201511	Reprocessed Endoscopic Trocars and Sleeves	Stryker Sustainability Solutions	NLM	Class II	2020-07-31
K201442	Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers	Diatron Group	LAF	Class II	2020-07-31
K201087	CORBEL Spacers	Globus Medical, Inc.	OVD	Class II	2020-07-31
K201069	VibrantVue Scleral Saline	Dry Eye Innovations, LLC	MRC	Class II	2020-07-31
K200803	BEAR and BEAR mini	Foreo Inc	NFO	Class II	2020-07-31
K200791	Navigation Enabled Intruments	Medos International SARL	OLO	Class II	2020-07-31
K200584	xPORT 304 (miCOR) System Lens Fragmentation System	Carl Zeiss Meditec Cataract Technology Inc	HQC	Class II	2020-07-31
K200039	P pro Crown & Bridge	Deltamed GmbH	EBG	Class II	2020-07-31
K193237	Carto Octaray Mapping Catheter with Trueref Technology	Biosense Webster Inc	MTD	Class II	2020-07-31
K192499	Cyber Blade	SIDAM S.r.l.	GCJ	Class II	2020-07-31
K192294	I Do	I do Biotech Co., Ltd.	DZE	Class II	2020-07-31
K191101	Kendall NPWT Incision Management Dressing Kit	Cardinalhealth	OMP	Class II	2020-07-31
K190790	Flex Fit	Dk Mungyo Corporation	EBI	Class II	2020-07-31
K201851	EXULT Femoral component trial - Left, EXULT Femoral component trial - Right	Corentec Co., Ltd.	JWH	Class II	2020-07-30
K201834	HI-TORQUE PROCEED Guide Wire Family	Abbott Vascular	DQX	Class II	2020-07-30
K201786	Arthrex Mini Hip PushLock	Arthrex GmbH	MAI	Class II	2020-07-30
K201648	Sterispine™ PS	Safe Orthopaedics	NKB	Class II	2020-07-30
K201543	MAGEC® System	NuVasive Specialized Orthopedics, Inc.	PGN	Class II	2020-07-30
K201186	KY Grosz Jelly	Rb Health (Us), LLC	NUC	Class II	2020-07-30
K201059	S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	IYN	Class II	2020-07-30