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 825 of 3530

510(k) clearances, page 825 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123571	Cardio Vision Mics Aortic Clamps	Cardiomedical GmbH	DXC	Class II	2013-08-01
K123399	Myovision 3.0 Wirefree System	Precision Biometrics, Inc.	IKN	Class II	2013-08-01
K132043	Arthrex Speedcinch	Arthrex GmbH	GAT	Class II	2013-07-31
K132041	Rextar X	Meta Biomed Co., Ltd.	EHD	Class II	2013-07-31
K132040	Vial Connector 13Mm Closed Collar	West Pharma. Services IL, Ltd.	LHI	Class II	2013-07-31
K131942	Nmi Picc III Catheter, Nmi Hpicc III Catheter	Boston Scientific Corporation	LJS	Class II	2013-07-31
K131936	Jbaids Tularemia Detection Kit	BioFire Diagnostics, LLC	OEH	Class II	2013-07-31
K131754	Wondfo Cocaine Urine Test (Coc 100), Wondfo Cannabinoids Urine Test (Thc 40)	Guangzhou Wondfo Biotech Co., Ltd.	DIO	Class II	2013-07-31
K131729	Jbaids Plague Detection Kit	BioFire Diagnostics, LLC	OIH	Unclassified	2013-07-31
K130923	5F Dignity CT Titanium Port	Medical Components, Inc.	LJT	Class II	2013-07-31
K130181	Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose Monitoring System	Infopia Co, Ltd.	NBW	Class II	2013-07-31
K130144	Abl90 Flex	Radiometer Medical ApS	CHL	Class II	2013-07-31
K123908	Omnipore Surgical Implants and Accessories	Matrix Surgical USA	KKY	Class II	2013-07-31
K132008	6981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead Extender Kit, 5866-24M Lead Adaptor Kit, 5866-38M Lead Adap	Medtronic, Inc.	DTD	Class II	2013-07-30
K131955	Neuroblate(tm) System	Monteris Medical Corp	GEX	Class II	2013-07-30
K131449	Coalition Spacer	Globus Medical, Inc.	OVE	Class II	2013-07-30
K131150	Cura Compensator	Cura Medical Technologies, LLC	IXI	Class II	2013-07-30
K130949	Cp4 Osseotite Certain Dental Implants	ZimVie US Corp LLC	DZE	Class II	2013-07-30
K130621	Broadmaster Healthcare System	Broadmaster Biotech Corporation	NBW	Class II	2013-07-30
K130302	Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.l.i.s. Polyaxial Pedicle Screw Fixat	Spinevision Inc.	MNI	Class II	2013-07-30
K124000	Medapps 2.0 - Remote Patient Monitoring System	Medapps Inc., dba Alere Connect	DRG	Class II	2013-07-30
K122532	Da Vinci Single-Site Instruments and Accessories	Intuitive Surgical, Inc.	NAY	Class II	2013-07-30
K122458	Verizon Wireless Remote Health Management System	Cello Partnership D/B/A Verizon Wireless	DRG	Class II	2013-07-30
K131710	Merit Hydrophilic Guide Wire	Merit Medical Systems, Inc.	DQX	Class II	2013-07-29
K131361	Warmtouch Surgical Access Blanket, Warmtouch Torso Blanket	Medtronic, Inc.	DWJ	Class II	2013-07-29
K131182	Multifix S Knotless Fixation Device	Arthocare Corporation	MBI	Class II	2013-07-29
K130855	PTFE Super Sheath Introducer	Martech Medical Products	DYB	Class II	2013-07-29
K130381	Angiojet Ultra Power Pulse Kit	Medrad, Inc.	QEW	Class II	2013-07-29
K130059	Endofast Reliant Scp, Endofast Reliant Lap	Ibi Israel Biomedical Innovations, Ltd.	PBQ	Class II	2013-07-29
K123831	Ophtacath Kit	France Chirurgae Instrumentation	OKS	Unclassified	2013-07-29
K122091	Cook Turbo-Flo Hd Acute Hemodialysis Catheter Set/tray Cook Spectrum Turbo-Flo Hd Acute Hemodialysis Catheter Set/tray	Cook Inc.	MPB	Class II	2013-07-29
DEN130010	Vysis Egr1 Fish Probe Kit - Sc (Specimen Characterization)	Abbott Molecular, Inc.	PDO	Class II	2013-07-29
K131999	Hba1c Control, Level 1 and Level 2	Randox Laboratories, Limited	JJX	Class I	2013-07-26
K131931	Chemtrue(r) Hcg Pregnancy Urine Midstream Test	Chemtron Biotech, Inc.	LCX	Class II	2013-07-26
K131814	Amecath Dual Lumen Implanted Hemodialysis Catheter	Ameco Medical Industries	MSD	Class II	2013-07-26
K131595	Eurotrol Gas-Ise Hct Qc and Eurotrol Gas-Ise Hct Lvm	Eurotrol B.V.	JJY	Class I	2013-07-26
K131549	Chemolock, Chemolock Port	Abbott Medical	ONB	Class II	2013-07-26
K131448	3D Prostate Suite 3Dtrus Prostate Mapping, Mri/3dtrus Fusion Option, Second Look 3Dtrus Fusion Option	Koelis	LLZ	Class II	2013-07-26
K131264	Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws	Gebr. Brasseler GmbH & Co. KG	HWC	Class II	2013-07-26
K131117	Zirmon Series	Kuwotech Co., Ltd.	EIH	Class II	2013-07-26
K130785	Seer 1000	Getemed Medizin- und Informationstechnik AG	MWJ	Class II	2013-07-26
K130680	Acrytone, Rezen Nf, and ISO Fast Denture Resins	Dentsoll, Inc.	EBI	Class II	2013-07-26
K130623	Barrx Channel Rfa Endoscopic Catheter	Medtronic, Inc.	KNS	Class II	2013-07-26
K130500	Capillarys Immunotyping, Capillarys 2 Instrument, It/if Control, Capillarys 2 Flex Piercing Instrument	Sebia, Inc.	CEF	Class I	2013-07-26
K130478	Sustain and Sustain Radiolucent Spacers	Globus Medical, Inc.	MAX	Class II	2013-07-26
K130410	Dental Unit with Chair	Xianyang North West Medical Instrument (Group) Co.	EIA	Class I	2013-07-26
K130331	Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker	Sauflon Pharmaceuticals, Ltd.	MVN	Class II	2013-07-26
K123768	Reliance Advance Endoscope Processing System	STERIS Corporation	NZA	Class II	2013-07-26
K123721	Gmk Revision Extension	Medacta International SA	JWH	Class II	2013-07-26
K122659	Vdrive W/v-Sono	Stereotaxis Inc	DQX	Class II	2013-07-26