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 2026-10-29, 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 808 of 3530

510(k) clearances, page 808 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K130101	Bytech	Bytech Dongtai Co., Ltd.	LYZ	Class I	2013-11-08
K122061	K-Y Brand Liquibeads	Johnson & Johnson Healthcare Products	NUC	Class II	2013-11-08
K132799	Clariso Pacs	Clariso, Inc.	LLZ	Class II	2013-11-07
K132456	Bd Veritor (Tm) System for Rapid Detection of Rsv	Becton Dickinson & Co	GQG	Class I	2013-11-07
K132222	Aquilion One Vision, V6.0	Toshibamedical Systems Corporation	JAK	Class II	2013-11-07
K132155	Merit ASAPLP Aspiration Catheter	Merit Medical Systems, Inc.	QEZ	Class II	2013-11-07
K132006	Sterile Nitrile Powder Free Examination Glove(vblu), Sterle Nitrile Powder Free Examination Glove(ablu)	Hartalega Sdn Bhd	LZA	Class I	2013-11-07
K131841	Kimberly-Clark Lavender Nitrile Powder-Free Exam Glove	Kimberly-Clark Corporation	LZA	Class I	2013-11-07
K131839	Dc 7	Dc International, LLC	GEX	Class II	2013-11-07
K131423	G-Arm Multiscan System	Beijing East Whale Imaging Technology Co., Ltd.	OXO	Class II	2013-11-07
K131355	Conceive Plus	Sasmar, Inc.	PEB	Class II	2013-11-07
K131240	Cochlear Baha Implant System, Cochlear Baha Attract	Cochlear Americas	LXB	Class II	2013-11-07
K131236	Ucp Pregnancy Cassette Test, Dip/card Strip, Home Pregnancy Cassette Test, Midstream Test and Dip/card Strip	Ucp Biosciences, Inc.	LCX	Class II	2013-11-07
K132048	Barrier Easywarm Active Self-Warming Blanket	Molnlycke Health Care, US LLC	DWJ	Class II	2013-11-06
K132022	Lemaitre 8F Occlusion Catheter	LeMaitre Vascular Inc.	MJN	Class II	2013-11-06
K131519	Belmont Hyperthermia Pump	Belmont Medical Technologies	LGZ	Class II	2013-11-06
K130978	Ztx Ultrasonic Diathermy Device	Zetroz, Inc.	PFW	Class II	2013-11-06
K130419	Papaya Plus, Digital Extraoral Source X-Ray System	Genoray Co., Ltd.	MUH	Class II	2013-11-06
K130405	Rusch Easycric Emergency Cricothyrotomy Set	Teleflex Medical	BWC	Class II	2013-11-06
K130357	Superdimension Triple-Needle Cytology Brush	Medtronic, Inc.	BTG	Class II	2013-11-06
K113135	Unistrip 1	Unistrip Technologies LLC	NBW	Class II	2013-11-06
K132567	Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle Peripherally Inserted Central Catheter Dual Lumen	Medtronic, Inc.	LJS	Class II	2013-11-05
K132561	Nuro Neuromodulation System	Advanced Uro-Solutions, Inc.	NAM	Class II	2013-11-05
K132307	Vida LED Surgical Lighting System	Convida Healthcare & Systems Corporation	FSY	Class II	2013-11-05
K132297	Em Sinus Dilation System	Medtronic Xomed, Inc.	LRC	Class I	2013-11-05
K132241	Gryphon Br Anchor W/ Proknot Technology, Gryphon Br Anchor W/ Proknot Technology - Hip, Gryphon Peek Anchor W/ Proknot T	DePuy Mitek, Inc.	MAI	Class II	2013-11-05
K132047	Lemills Valvulotome	LeMaitre Vascular Inc.	MGZ	Class II	2013-11-05
K131661	Infusion Syringe Set	Innovative Medical Manufacturing Co.	FMF	Class II	2013-11-05
K131211	Dicompacs Dx-R with Flat Panel	Oehm und Rehbein GmbH	MQB	Class II	2013-11-05
K122400	Cardiox Flow Detection System	Cardiox Corp.	DXG	Class II	2013-11-05
K122338	Preferred Blood Glucose Monitoring System	Prodigy Diabetes Care, LLC	NBW	Class II	2013-11-05
K133134	X-Porte Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	2013-11-04
K131834	Wolf Long Bone Plate System	Toby Orthopaedics	HRS	Class II	2013-11-04
K131700	Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use Polypectomy Snares	Boston Scientific Corporation	FDI	Class II	2013-11-04
K131655	Lighthouse(tm) Urinary Catheter	Seedings Life Science Ventures, LLC	EZL	Class II	2013-11-04
K131566	Arix Hand System	Jeil Medical Corporation	HRS	Class II	2013-11-04
K131518	Mectacer Biolox Option Heads	Medacta International SA	LZO	Class II	2013-11-04
K132883	Hemodia Arthroscopy Pump Tube Sets (Hats)	Hemodia SAS	HRX	Class II	2013-11-01
K132831	Quiet/silent Scanning Suite	Siemens Medical Solutions USA, Inc.	LNH	Class II	2013-11-01
K132450	Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal Bond	Kuraray Noritake Dental, Inc.	KLE	Class II	2013-11-01
K132124	Klarity Vacuum Bag, Klarity Mold Cushion	Klarity Medical Products LLC	IYE	Class II	2013-11-01
K132109	Enamelast	Ultradent Products Inc. / Oratech, LLC	LBH	Class II	2013-11-01
K131695	Rayscan a-Expert 3D	Ray Co., Ltd.	OAS	Class II	2013-11-01
K131693	Rayscan a-Expert	Ray Co., Ltd.	MUH	Class II	2013-11-01
K131669	Perimeter Interbody Fusion Device	Medtronic Sofamor Danek USA Inc	MAX	Class II	2013-11-01
K131420	Petite Basic System 701 Elt	MEGO AFEK AC Ltd.	JOW	Class II	2013-11-01
K130845	Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview	Ambu A/S	EOQ	Class II	2013-11-01
K130649	Silk Road Access Catheter	Silk Road Medical	DQY	Class II	2013-11-01
K130195	Scanning Laserlink	Lumenis Ltd	HQF	Class II	2013-11-01
K123514	Clearpath Aligner	Qserve America, Inc.	NXC	Class II	2013-11-01