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 687 of 3530

510(k) clearances, page 687 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K152633	Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe	Edwards Lifesciences LLC	LDF	Class II	2015-10-15
K152455	Amendia Cervical Plate System	Spinal Elements, Inc	KWQ	Class II	2015-10-15
K152453	LENSAR Laser System - fs 3D (LLS-fs 3D)	LENSAR, Inc	OOE	Class II	2015-10-15
K152035	iSnare system-Lariat	United States Endoscopy Group, Inc.	FBK	Class II	2015-10-15
K152005	MONTAGE Settable, Resorbable Hemostatic Bone Putty	Orthocon, Inc.	MTJ	Unclassified	2015-10-15
K151988	Visible Patient Suite	Visible Patient, SAS	LLZ	Class II	2015-10-15
K151466	MrOpen	Paramed S.r.l.	LNH	Class II	2015-10-15
K151300	AVERT Contrast Modulation System	Osprey Medical, Inc.	DXT	Class II	2015-10-15
K150835	LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip	Medtronic, Inc.	GEI	Class II	2015-10-15
K150173	Aerobika OPEP Devive with Manometer	Trudell Medical International	BWF	Class II	2015-10-15
K152668	truFreeze System	CSA Medical	GEH	Class II	2015-10-14
K152621	OSS/Arcos IM Total Femur Rod	Zimmer GmbH	JDI	Class II	2015-10-14
K152275	Pantheris System	Avinger, Inc.	MCW	Class II	2015-10-14
K151785	Px HA PEEK IBF System	Innovasis, Inc	MAX	Class II	2015-10-14
K151724	AngioDynamics Mariner Angiographic Catheters	Boston Scientific Corporation	DQO	Class II	2015-10-14
K151571	Mini Needle	Ocujet, LLC	FMI	Class II	2015-10-14
K151220	Dunamis Interference Screw	Dunamis, LLC	MBI	Class II	2015-10-14
K150788	Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices	Meditech Spine, LLC	ODP	Class II	2015-10-14
K150717	Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron	M/s. Meril Endo Surgery Private Limited.	GAM	Class II	2015-10-14
K150396	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	Apex Biotechnology Corp.	NBW	Class II	2015-10-14
K152516	BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks	Becton Dickinson & Co	JTN	Class II	2015-10-13
K152308	Sensor Medical Single Use Tonometer Prism	Sensor Medical Technology, LLC	HKY	Class II	2015-10-13
K152140	Boa Endoscopic Valve	PENTAX of America, Inc.	OCX	Class II	2015-10-13
K152109	HD-Camera HDC1000	Novanta Medical GmbH	FET	Class II	2015-10-13
K150693	PHIN-FX Cannulated Lag Screw System	Ascent Medical, LLC	HWC	Class II	2015-10-13
K150687	DripAssist	Shift Labs	FLN	Class II	2015-10-13
K143308	GelPOINT Transvaginal Access Platform	Applied Medical Resources Corp	HEW	Class II	2015-10-13
K140325	Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System	Joinsoon Medical Technology Co, Ltd.	NBW	Class II	2015-10-13
K143577	XW-100 Automated Hematology Analyzer, XW QC CHECK	Sysmex America, Inc.	GKZ	Class II	2015-10-12
K151919	Vitrea CT Lung Density Analysis Software	Canon Medical Informatics, Inc.	JAK	Class II	2015-10-10
K150306	D2RS_AT Digital Dynamic Remote System	Stephanix Radiological Solutions	JAA	Class II	2015-10-10
K152565	Auto Suture Locking Trocar	Medtronic, Inc.	GCJ	Class II	2015-10-09
K152036	SOMATOM Definition Edge, SOMATOM Definition AS/AS+	Siemens Medical Solutions USA, Inc.	JAK	Class II	2015-10-09
K151833	Aquilion Lightning (TSX-035A/2, V7.0)	Toshibamedical Systems Corporation	JAK	Class II	2015-10-09
K151746	Dyevert Contrast Modulation System	Osprey Medical, Inc.	DXT	Class II	2015-10-09
K151719	Reve134	Kw Ear Lab, Inc.	KLW	Class II	2015-10-09
K151693	Dr-Ho's Foot Pad Electrode	DRTV Asia Ltd	GXY	Class II	2015-10-09
K151596	Endoskeleton TCS Interbody Fusion Device	Titan Spine, LLC	OVE	Class II	2015-10-09
K151541	G-Fix	GC America Inc.	EBF	Class II	2015-10-09
K151528	Powder Free Nitrile (Black) Examination Gloves	Gallant Quality Sdn. Bhd.	LZA	Class I	2015-10-09
K151525	Amia Automated PD System with Sharesource	Deka Research & Development Corp.	FKX	Class II	2015-10-09
K151242	SterilContainer S	Aesculap Inc	KCT	Class II	2015-10-09
K151044	CLICKLINE Scissor Insert for Single Use	Karl Storz Endoscopy-America, Inc.	GEI	Class II	2015-10-09
K150502	DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls	Microgenics Corporation	DJG	Class II	2015-10-09
K143499	eCligner	Eclear International Co., Ltd.	NXC	Class II	2015-10-09
DEN150011	Sonablate 450	Sonacare Medical, LLC	PLP	Class II	2015-10-09
K152591	Medilas H RFID Laser Fibers	Dornier Medtech America, Inc.	GEX	Class II	2015-10-08
K152577	Ultrasound System Sonimage Hs 1	Konica Minolta, Inc.	IYN	Class II	2015-10-08
K152550	Medicalgorithmics Unified Arrhythmia Diagnosic System	Medicalgorithmics S.A.	DSI	Class II	2015-10-08
K152240	Passeo-14 Peripheral Dilatation Catheter	BIOTRONIK AG	LIT	Class II	2015-10-08