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 2026-10-26, 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 668 of 3530

510(k) clearances, page 668 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K151569	Tranberg CLS Laser Fiber	Clinical Laserthermia Systems AB	GEX	Class II	2016-02-12
K151429	QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols	Inova Diagnostics, Inc.	LLL	Class II	2016-02-12
K151404	ProTrach Dualcare	Atos Medical AB	JOH	Class II	2016-02-12
K150487	X-Suit NIR Biliary Metallic Stent	Medinol Ltd.	FGE	Class II	2016-02-12
K150277	Pain Therapy System, Model PTS-II	Counter Scientific Development (Gz), Ltd.	NUH	Class II	2016-02-12
K153605	ivWatch Model 400	Ivwatch, LLC	PMS	Class II	2016-02-11
K153080	RTVue XR OCT Avanti with AngioVue Software	Optovue Inc.	HLI	Class II	2016-02-11
K152991	OptoWire Deux	Opsens Inc.	DQX	Class II	2016-02-11
K152568	C-Vbr	Cardinal Spine, LLC	PLR	Class II	2016-02-11
K152555	Dental Implant System	Ariabio International, Inc.	DZE	Class II	2016-02-11
K152185	Architect Shbg	Biokit, S.A.	CDZ	Class I	2016-02-11
K151918	Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist	Bausch & Lomb Incorporated	LPL	Class II	2016-02-11
K151529	Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator	Siemens Healthcare Diagnostics Inc.	CDZ	Class I	2016-02-11
K153589	CD HORIZON Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2016-02-10
K153232	Cios Select	Siemens Medical Solutions USA, Inc.	OWB	Class II	2016-02-10
K153144	Tio-H Digital Radiography Sensor	Denttio, Inc.	MUH	Class II	2016-02-10
K151553	Anterior Cervical Plate System	Osteomed Implantes, Ltda	KWQ	Class II	2016-02-10
K151311	Safe Block Pen Needle	Artsana S.P.A	FMI	Class II	2016-02-10
K150826	Nutra Face Lift Model PE8050	Nutra Luxe MD, LLC	NFO	Class II	2016-02-10
K153340	Epic Extremity Plate System	Epic Extremity, LLC	HRS	Class II	2016-02-09
K153066	BostonSight IC Corneal Lens, BostonSight IC Scleral Lens	BOSTON FOUNDATION for SIGHT/BostonSight TECH	HQD	Class II	2016-02-09
K152898	Diode Laser Therapy Systems	Beijing Sincoheren Science and Tech. Development Co., Ltd.	GEX	Class II	2016-02-09
K152739	Electronic Thermometer	Guangdong Biolight Meditech Co., Ltd	FLL	Class II	2016-02-09
K152645	Dictum Health	Dictum Health, Inc.	MWI	Class II	2016-02-09
K152476	Exofin High Viscosity Tissue Adhesive	Chemence Medical Products, Inc.	MPN	Class II	2016-02-09
K152297	OBS Anchorage Screw	Bomei Co., Ltd.	OAT	Class II	2016-02-09
K152278	ENDOFLOW II - Irrigation, Warming and Suction System	Promepla S.A.M	OCX	Class II	2016-02-09
K152271	Powder Free Nitrile Patient Examination Gloves, Black color	Suqian Xingye Glove Co,Ltd	LZA	Class I	2016-02-09
K151772	Actreen Mini Intermittent Urinary Catheters	B.Braun Medical, Inc.	GBM	Class II	2016-02-09
K151635	CapsoCam (SV-1)	CapsoVision, Inc.	NEZ	Class II	2016-02-09
K151308	Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set	Schoelly Fiberoptic, GmbH	FGA	Class II	2016-02-09
K151237	Nutrisafe 2- ENFit Adaptor	Vygon	PIO	Class II	2016-02-09
K160068	FilmArray Respiratory Panel (RP) for use with FilmArray Torch	BioFire Diagnostics, LLC	OCC	Class II	2016-02-08
K152868	ExpressBraid Graft Manipulation	Biomet Manufacturing Corp	GAT	Class II	2016-02-08
K152743	M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)	Microline Surgical, Inc	KCT	Class II	2016-02-08
K151475	EndoChoice Select Injection Needle	Boston Scientific Corporation	FBK	Class II	2016-02-08
K153530	Bridge Occlusion Balloon	Spectranetics Corp.	MJN	Class II	2016-02-05
K153508	Stryker CMF MEDPOR Customized Implant	Stryker Corp.	FWP	Class II	2016-02-05
K153489	Cryocare CS Surgical System	Varian Medical Systems, Inc.	GEH	Class II	2016-02-05
K153173	MOR Implant System	Sterngold Dental LLC	DZE	Class II	2016-02-05
K153054	N5-1	Nuga Medical Co Ltd	JFB	Class II	2016-02-05
K153028	Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue	Zibo Huiying Medical Products, Co., Ltd.	LYZ	Class I	2016-02-05
K152819	Amecath Peripheral inserted Central Venous Catheter Sets	Ameco Medical Industries	LJS	Class II	2016-02-05
K152427	Pc ECG	Edan Instruments, Inc.	DPS	Class II	2016-02-05
K152168	Love Liquid Personal Lubricant	The Kama Sutra Company	NUC	Class II	2016-02-05
K151955	YuGo System	Biogaming, Ltd.	LXJ	Class II	2016-02-05
K151835	Vital Signs Patch System	Lifewatch Technologies, Ltd.	DSI	Class II	2016-02-05
K151185	AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)	ABL Medical, LLC	FRO	Unclassified	2016-02-05
K151069	SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle	Spectra Medical Devices, LLC	BSP	Class II	2016-02-05
K143596	Miniars Screws	Overmed SRL.	HWC	Class II	2016-02-05