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 430 of 3528

510(k) clearances, page 430 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K192645	Trigon™ Ti Stand-Alone Wedge Fixation System	Nvision Biomedical Technologies, Inc	PLF	Class II	2019-12-23
K192487	EZ-TRAX Containment Device	K1 Medical, LLC	KCT	Class II	2019-12-23
K192485	BioCode Respiratory Pathogen Panel (RPP)	Applied BioCode, Inc.	OCC	Class II	2019-12-23
K192104	Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs)	MEDLINE INDUSTRIES, LP - Northfield	LZA	Class I	2019-12-23
K192023	Arm Blood Pressure Monitor	Truly Instrument Limited	DXN	Class II	2019-12-23
K191960	Arthrex Univers Revers Modular Glenoid System	Arthrex GmbH	PHX	Class II	2019-12-23
K191846	MAXReach Laser Probe	Vortex Surgical, Inc.	HQB	Class II	2019-12-23
K191551	RIST Cath Radial Access Long Sheath	Rist Neurovascular, Inc.	DQY	Class II	2019-12-23
K190860	Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color	Ever Growth (Vietnam) Co., Ltd.	LZA	Class I	2019-12-23
K190736	Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs	Ever Growth (Vietnam) Co., Ltd.	LZA	Class I	2019-12-23
K190665	Neodent Instrument Kit Cases	JJGC Industria e Comercio de Materiais Dentarios SA	KCT	Class II	2019-12-23
K182718	Mini and Micro Fragments Reconstruction System – GMReis	Gm dos Reis Industria E Comerico Ltda.	HRS	Class II	2019-12-23
DEN180067	Mucosal Integrity Conductivity (MI) Test System	Diversatek Healthcare Inc	QIS	Class II	2019-12-23
K192629	Spinalytics	Optima Health Solutions International Corp.	LXM	Unclassified	2019-12-21
K192559	Acetabular Bone Screws (for MobileLink Acetabular Cup System)	Waldemar Link GmbH & Co. KG	LZO	Class II	2019-12-21
K193292	Voyant 5mm Fusion Device, Voyant Maryland Fusion Device	Applied Medical Resources Corp	GEI	Class II	2019-12-20
K193269	UroLift System (UL400)	Neotract Inc	PEW	Class II	2019-12-20
K193238	Nexus DR Digital X-Ray Imaging System (with vSharp)	Varex Imaging Corporation	MQB	Class II	2019-12-20
K193235	Telepack +	Karl Storz Endoscopy-America, Inc.	FET	Class II	2019-12-20
K193230	Ziehm Vision FD	Ziehm Imaging GmbH	OWB	Class II	2019-12-20
K193116	MRopen EVO	ASG Superconductors S.p.A.	LNH	Class II	2019-12-20
K193018	Surgical Direct Hand-held Laparoscopic Instruments	Surgical Direct, Inc.	GEI	Class II	2019-12-20
K192990	Litho Evo	Quanta System Inc.	GEX	Class II	2019-12-20
K192873	SX-One MicroKnife	SONEX HEALTH, Inc	LXH	Class I	2019-12-20
K192833	Indigo Aspiration System	Penumbra Inc.	QEW	Class II	2019-12-20
K192755	Soli-Lite LG4 Galileo	Silhouet-Tone Corporation	GEX	Class II	2019-12-20
K192718	Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology	Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.)	MAX	Class II	2019-12-20
K192711	Dannik Titanium Ligation Clip	Dannik	FZP	Class II	2019-12-20
K192471	RHIN1 Stylus	Aerin Medical, Inc.	GEI	Class II	2019-12-20
K192470	DenMat Orthodontic Aligners	Denmat Holdings, LLC	NXC	Class II	2019-12-20
K192383	BriefCase	Aidoc Medical Ltd.	QAS	Class II	2019-12-20
K192178	R&D Series Nova Compo N	Imicryl Dis Malzemeleri Sanayi ve Ticaret A.S.	EBF	Class II	2019-12-20
K192040	AVIEW Modeler	Coreline Soft Co., Ltd.	LLZ	Class II	2019-12-20
K192027	WEREWOLF COBLATION System, COBLATION HALO Wand	ArthroCare Corporation	GEI	Class II	2019-12-20
K191967	Unyvero LRT BAL Application	Curetis GmbH	QBH	Class II	2019-12-20
K191879	DRX-Evolution with Carestream Digital Tomosynthesis	Eastman Kodak Company	KPR	Class II	2019-12-20
K191836	Ceramill A-Splint	Amann Girrbach AG	MQC	Unclassified	2019-12-20
K191823	Clear-Aligners	CDB Corporation	NXC	Class II	2019-12-20
K191666	Unscented W long plastic and cardboard applicator tampons	Ontex Bvba	HEB	Class II	2019-12-20
K191647	QLAB Advanced Quantification Software	Philips Health Care	QIH	Class II	2019-12-20
K191440	Paragonix SherpaPak Pancreas Transport System	Paragonix Technologies Inc.	KDN	Class II	2019-12-20
K191403	Pulse Oximeter	Nonin Medical, Inc	DQA	Class II	2019-12-20
K191350	ACTIVE® Free Testosterone RIA	IMMUNOTECH s.r.o.	CDZ	Class I	2019-12-20
K191234	APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets	ERBE Elektromedizin GmbH	GEI	Class II	2019-12-20
K190929	xvision Spine system (XVS)	Augmedics Ltd.	SBF	Class II	2019-12-20
K190805	PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL	PENTAX of America, Inc.	PEA	Class II	2019-12-20
K190756	Iodoflex	Smith & Nephew Medical Ltd	FRO	Unclassified	2019-12-20
K190730	Iodosorb	Smith & Nephew Medical Ltd	FRO	Unclassified	2019-12-20
K190633	NanoOrtho NanoKnee® System	Nanoortho, LLC	HRY	Class II	2019-12-20
K190284	Bengal Stackable Cage System	Medos International SARL	PLR	Class II	2019-12-20