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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 544 of 3529

510(k) clearances, page 544 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K172180	Oscar 15	Genoray Co., Ltd.	OWB	Class II	2018-02-09
K172160	Southern Implants PEEK Abutments	Southern Implants, (Pty.) Ltd.	NHA	Class II	2018-02-09
K171755	CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System	Omega Medical Imaging, LLC	OWB	Class II	2018-02-09
K171631	Standard Catheter Set	Varian Medical Systems, Inc.	JAQ	Class II	2018-02-09
K171455	AT-6XX Series Infrared Thermometer	Xiamen Acurio Instruments Co., Ltd.	FLL	Class II	2018-02-09
K171179	BR Type Implant System	Biotem Co., Ltd.	DZE	Class II	2018-02-09
K180091	UNiD Spine Analyzer	Medicrea International	LLZ	Class II	2018-02-08
K180084	Ultrasound System SONIMAGE MX1	Konica Minolta, Inc.	IYO	Class II	2018-02-08
K173805	NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)	Marvao Medical Devices Ltd.	MSD	Class II	2018-02-08
K173553	LUCAS 3 Chest Compression System	Jolife AB	DRM	Class II	2018-02-08
K173537	Concorde Lift™	Medos International SARL	MAX	Class II	2018-02-08
K173411	Comprehensive Segmental Revision System (SRS)	Biomet Manufacturing Corp	PHX	Class II	2018-02-08
K173335	Gazelle PTFE and Suture Delivery Device	Dura Tap, LLC	NBY	Class II	2018-02-08
K173244	superDimension Navigation System V7.2	Medtronic, Inc.	JAK	Class II	2018-02-08
K173025	NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System	Nu Vasive, Incorporated	MAX	Class II	2018-02-08
K162727	SENYINT Remote Consultation System	Dalian Senyint Digital Medical System Co., Ltd.	LLZ	Class II	2018-02-08
K180067	ACUSON X800 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2018-02-07
K173826	THP Hip Fracture Plating System	Zimmer GmbH	JDO	Class II	2018-02-07
K173450	PRESS DUO elite, PRESS DUO elite AG	Nemoto Kyorindo Co., Ltd.	DXT	Class II	2018-02-07
K173199	PicoSure Workstation	Cynosure, LLC	GEX	Class II	2018-02-07
K172698	G-Beam Fusion Beaming System	Orthofix SRL	HWC	Class II	2018-02-07
K171861	CAPILLARYS Hb A1c	Sebia, Inc.	PDJ	Class II	2018-02-07
K171520	SteriZign Signatur Device Protection System	Sterizign Precision Technologies	KCT	Class II	2018-02-07
K161222	PENTAX MEDICAL ED-3490TK, Video Duodenoscope	PENTAX of America, Inc.	FDT	Class II	2018-02-07
K173882	SeaSpine Mariner Pedicle Screw System	SeaSpine Orthopedics Corporation	NKB	Class II	2018-02-06
K173528	Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System	Devon Medical Products (Jiangsu) Ltd	JOW	Class II	2018-02-06
K172953	Acid Etchant	American Orthodontics	KLE	Class II	2018-02-06
K172832	Insight BD	Siemens Medi Cal Solutions, Inc.	LLZ	Class II	2018-02-06
K172490	eUnity	Client Outlook, Inc.	LLZ	Class II	2018-02-06
K171641	Accula Flu A/Flu B Test	Mesa Biotech, Inc.	OZE	Class II	2018-02-06
K171557	AcQRef Introducer Sheath	Acutus Medical, Inc.	DYB	Class II	2018-02-06
K171375	Gammex PI Breach Detect Powder Free Surgical Glove	Ansell Healthcare Products LLC	KGO	Class I	2018-02-06
K173924	DRX-Revolution Nano Mobile X-ray System	Eastman Kodak Company	IZL	Class II	2018-02-05
K173672	FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter	Inari Medical, Inc.	QEW	Class II	2018-02-05
K173512	MFI-Cardiac	Multifunctional Imaging LLC	LLZ	Class II	2018-02-05
K173433	ProxiDiagnost N90	Philips Medical Systems DMC GmbH	OWB	Class II	2018-02-05
K173204	RS85 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2018-02-05
K172040	Aquilex Fluid Control System AQL-100S	Novanta Medical GmbH	HIG	Class II	2018-02-05
K171695	First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana	WHPM Inc.	NFT	Class II	2018-02-05
K171516	Flip Lube	Imquest Biosciences, Inc.	NUC	Class II	2018-02-05
K171361	Bettercare Platform - Advanced Web Client	Better Care S.L.	MWI	Class II	2018-02-05
K171208	Trans-anal Introducer	Visionsense, Ltd.	FED	Class II	2018-02-05
K180070	SpeediCath Flex Coude Pro	MEDLINE INDUSTRIES, LP - Northfield	GBM	Class II	2018-02-02
K180036	SMAXEL CO2 Surgical Laser System	Ids, Ltd.	ONG	Class II	2018-02-02
K173981	ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc. Ultrasound Group	IYN	Class II	2018-02-02
K173849	Triathlon Total Knee System	Stryker Orthopaedics	MBH	Class II	2018-02-02
K173800	Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage	Camber Spine Technologies	MQP	Class II	2018-02-02
K173445	Materialise TKA Guide System	Materialise N.V.	JWH	Class II	2018-02-02
K172512	ACRO HCG Pregnancy Rapid Test	ACRO BIOTECH Inc.	LCX	Class II	2018-02-02
K172237	Bicera Resorbable Bone Substitute	Wiltrom Corporation Limited	MQV	Class II	2018-02-02