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 997 of 3531

510(k) clearances, page 997 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101935	Centervue Digital Retinography System	Centervue	HKI	Class II	2010-10-27
K101712	Endovascular Laer Vein System Kit	Biolitec, Inc.	GEX	Class II	2010-10-27
K100499	Orgentec Rheumatoid Factor Eia	Orgentec Diagnostika GmbH	DHR	Class II	2010-10-27
K092333	Pathiam System with Iscan for P53 and Ki-67	Bioimagene, Inc.	NQN	Class II	2010-10-27
K103121	Eco-S	Vericom Co., Ltd.	EBC	Class II	2010-10-26
K103010	Stryker Patient Specific Polymer Implant	Howmedica Osteonics Corp., dba Stryker Orthopaedics	KKY	Class II	2010-10-26
K102801	Phtip Disposable Isfet Catheter	E-Cath Co., Ltd.	FFX	Class II	2010-10-26
K102758	Trulight 5520 and Trulight 5320	Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg	FSY	Class II	2010-10-26
K102523	Multi-Lead Trialing Cable Model 355531	Medtronic, Inc.	GZB	Class II	2010-10-26
K102420	Embol-X Access Device/ Aortic Cannula, Embol-X Slim Accessdevice/ Aortic Cannula, Embol-X Glide Access Device/ Aortic Ca	Edwards Lifesciences LLC	DWF	Class II	2010-10-26
K102110	24 Widen Wheelchair (Jy/ct-H28), 18 Reclining Wheelchair (Jy-260), 18 Light Weight Wheelchair (Jy/ct-H06), 18 Alumin	Foshan Shunde Jaeyong Hardware Co., Ltd.	IOR	Class I	2010-10-26
K101951	Light Cure Retainer	Reliance Orthodontic Products, Inc.	DYH	Class II	2010-10-26
K101756	Tsc	Sybron Dental Specialties, Inc.	MVL	Unclassified	2010-10-26
K101718	Osseoconduct	Steiner Laboratories Div of Steiner Healthcare, LLC	LYC	Class II	2010-10-26
K101571	Xper Information Management and Flex Cardio Physiomonitoring Systems	Invivo Corporation	MWI	Class II	2010-10-26
K101355	Augease Vascular Augmentation Device	Augdvt, LLC	JOW	Class II	2010-10-26
K100489	Dxh 300 Coulter Cellular Analysis System, Dxh 300C Coulter Cellular Analyssi System Model: 71772, 71771	Beckman Coulter Cellular	GKZ	Class II	2010-10-26
K091393	Elekta Neuromag with Maxfilter	Elekta Neuromag Oy	OLX	Class II	2010-10-26
K101683	Infiniti Cyp2c19 Assay	Autogenomics, Incorporated	NTI	Class II	2010-10-25
K101235	Cranial Loop Cranial Bone Fixation System	Neos Surgery S.L.	GXR	Class II	2010-10-25
K093069	Nxstage System One with Therapeutic Plasma Exchange Cartridge	NxStage Medical Inc	KDI	Class II	2010-10-23
K103095	Sprinter Legend 1.25Mm Rx and Sprinter Legend 1.25Mm Otw Balloon	Medtronic Ireland	LOX	Class II	2010-10-22
K102991	M5 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYO	Class II	2010-10-22
K102680	Z-Motion Digital Diagnostic X-Ray System	Control-X Medical, Inc.	KPR	Class II	2010-10-22
K102526	Blo2x Oxygen Blocker	Pascal International, Inc.	EBF	Class II	2010-10-22
K102168	Sensei X Robotic Catheter System	Hansen Medical, Inc.	DXX	Class II	2010-10-22
K102135	Vector Event Grid Architecture (Vega) System	Nuvon, Inc.	MWI	Class II	2010-10-22
K102124	Dental Computed Tomography X-Ray System	Vatech Co., Ltd.	MUH	Class II	2010-10-22
K102003	Xpress Balloon Device	Entellus Medical, Inc.	LRC	Class I	2010-10-22
K101921	Vitros Immunodiagnostics Products Intact Pth Reagent Pack, Vitros Immunodiagnostics Products Intact Pth Calibrators, Vit	Ortho-Clinical Diagnostics, Inc.	CEW	Class II	2010-10-22
K101839	Kaneka Pharma America Xpress-Way Rx	Kaneka Pharma America, LLC	QEZ	Class II	2010-10-22
K101765	Kyphon Anchor Facet Screw System	Medtronic Spine, LLC	MRW	Unclassified	2010-10-22
K101759	Quantum Ring Fixation System Model Isf	Quantum Medical Concepts, LLC	KTT	Class II	2010-10-22
K101679	Arthrex Pushlock Anchors	Arthrex GmbH	MAI	Class II	2010-10-22
K101525	Pioneer Spinous Process Fusion Plate	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWP	Class II	2010-10-22
K100944	Clavicle Locking Plate System	Newclip Technics	HRS	Class II	2010-10-22
K100744	Certus 140 Microwave Ablation System and Accessories, Model Certus 140	Neuwave Medical, Inc.	NEY	Class II	2010-10-22
K100660	Infrared Ear Thermometer Model Dr. Schven Ict-1000	Innochips Technology Co., Ltd.	FLL	Class II	2010-10-22
K100248	Drfp Prosmart Root Canal Obturation System, Propoints 4% 6%, Pt, S	Drfp, Ltd.	KIF	Class II	2010-10-22
K100212	Dentacenter/expedition, Model Saf-430	Safari Dental, Inc.	EIA	Class I	2010-10-22
K100152	Sirona Cad/cam System	Sirona Dental Systems GmbH	NHA	Class II	2010-10-22
K093293	Vanguard 360 Revision Knee System	Zimmer GmbH	JWH	Class II	2010-10-22
K102890	K-Shield Small Vein Infusion / Winged Collection Set W/ Anti Needle Stick Protector (and Multisample Luer Adapter)	Kawasumi Laboratories America, Inc.	FPA	Class II	2010-10-21
K102611	Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Hyland Plastic Co., Ltd.	LYZ	Class I	2010-10-21
K102570	Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)	Tangshan Kangjie Glove Co., Ltd.	LYZ	Class I	2010-10-21
K102569	Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)	Tangshan Kangyuan Glove Co., Ltd.	LYZ	Class I	2010-10-21
K102562	Intellivue Patient Monitor, Models Mp2, X2, Mp5, Mp5t, Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80, Mp90, & Mx800	Philips Medizin Systeme Boblingen GmbH	MHX	Class II	2010-10-21
K102559	Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)	Tangshan Hengda Plastic Products Co., Ltd.	LYZ	Class I	2010-10-21
K102262	Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction Tool	ArthroCare Corporation	MBI	Class II	2010-10-21
K101896	Masimo Lncs/m-Lncs Oximetry Sensors	Masimo Corporation	DQA	Class II	2010-10-21