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 933 of 3530

510(k) clearances, page 933 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K110765	Fxa (Tm)	Aces GmbH	LLZ	Class II	2011-11-04
K110715	Interdry Silver	Milliken Healthcare Products, LLC	FRL	Class I	2011-11-04
K110246	Medisize Red and Medisize Blue	Qserve America, Inc.	CAH	Class II	2011-11-04
K103291	Biohorizons Laser-Lok Abutments for Nobel Biocare	BioHorizons Implant Systems Inc	NHA	Class II	2011-11-04
K103021	Element Plus Blood Glucose Monitoring System	Infopia Co, Ltd.	NBW	Class II	2011-11-04
K100811	Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400	Impedimed, Inc.	OBH	Class II	2011-11-04
K112945	Elitecore Full Core Biopsy Device 18Gax10cm, 18Gax15cm, 18Gax20, With/hilitier 18Gax10cm , W/hiliter 18Gax15cm	Inrad, Inc.	KNW	Class II	2011-11-03
K112381	Hi Torque Connect Guidewire	Lake Region Medical	DQX	Class II	2011-11-03
K112299	Endovascular Laser Vein System Kit	Biolitec Medical Devices, Inc.	GEX	Class II	2011-11-03
K111902	Aequalis Shoulder System	TORNIER Inc.	KWS	Class II	2011-11-03
K111648	Bracco Diagnostics, Inc. Co2mpact Endodcopic Insufflator	Bracco Diagnostic, Inc.	FCX	Class II	2011-11-03
K111643	Opto Mitra Yellow Laser	Opto Electronica SA	HQF	Class II	2011-11-03
K110989	Neurovision Ink Printed Endotracheal Tube Electrode	Neurovision Medical Products Inc	ETN	Class II	2011-11-03
K110738	Thermo Scientific Mas Omni-Core	Microgenics Corporation	JJY	Class I	2011-11-03
K103820	Reprobone Dental Grafting Material	Ceramisys Ltd	LYC	Class II	2011-11-03
K103691	Biohorizons Abutments for Zimmer	BioHorizons Implant Systems Inc	NHA	Class II	2011-11-03
K103547	Lightlas Multi-Wavelength Medical Laser System	Lightmed Corp.	HQF	Class II	2011-11-03
K102524	Futura	Dr. Oliver Wenker, M.D., M.B.A.	IMG	Class II	2011-11-03
K113036	U by Kotex Click Unscented Menstrual Tampons	Kimberly-Clark Corporation	HEB	Class II	2011-11-02
K112965	Nano Suture Anchor	Linvatec Corporation D/B/A Conmed Linvatec	MBI	Class II	2011-11-02
K112962	Spacelabs Healthcare Xprezzon Beside Monitor(9913930)	GE Healthcare	MHX	Class II	2011-11-02
K112931	Leucadia(tm) Mis Pedicle Screw System	Phygen, LLC	NKB	Class II	2011-11-02
K112262	Reflex Ballon Guide Catheter	Reverse Medical Corporation	DQY	Class II	2011-11-02
K112185	Foursnare Vascular Retrieval Snare	Cook Inc.	MMX	Class II	2011-11-02
K111474	Bingo Pro	Forum Engineering Technologies (96) Ltd.	LQY	Unclassified	2011-11-02
K111345	See Clear Soft Contact Lens, See Clear Color Soft Contact Lens, Fierce Soft Contact Lens	The See Clear Company	LPL	Class II	2011-11-02
K110554	Bioceramic Orbital Implant, Orbtex	Ceramisys Ltd	HPZ	Class II	2011-11-02
K110426	Dyna-Extor II	BK Meditech Co., Ltd.	KTT	Class II	2011-11-02
K102827	Medical Maggots, Lesoc	Monarch Labs, LLC	NQK	Unclassified	2011-11-02
K102378	Vectraplexecg System with Vectraplexami	VectraCor, Inc.	DPS	Class II	2011-11-02
K112951	Body Analysis Scale	Shenzhen Healthcare Electronic Technology Co., Ltd.	MNW	Class II	2011-11-01
K112932	Transtek	Zhongshan Transtek Electronics Co., Ltd	MNW	Class II	2011-11-01
K111028	Eus Balloon	United States Endoscopy Group, Inc.	FDF	Class II	2011-11-01
K110221	Eye-Cept Sterile Saline Solution	Optics Laboratory, Inc.	LPN	Class II	2011-11-01
K103338	Cooltouch	New Star Lasers, Inc.	PDZ	Class II	2011-11-01
K102047	Lci Option for Innocor	Innovision, Inc.	BZC	Class II	2011-11-01
K100784	Uc-Care Navigo Sytem	UC-Care	LLZ	Class II	2011-11-01
K112961	Clo-Surplus P.a.d.	Scion Cardio-Vascular, Inc.	QSY	Unclassified	2011-10-31
K112345	Distal Volar Radius Plating Systems	Medos International SARL	LXT	Class II	2011-10-31
K111683	Flight 60 Ventilator	Flight Medical Innovations Ltd.	CBK	Class II	2011-10-31
K112445	Sofreliner Tough S	Tokuyama Dental Corporation	EBI	Class II	2011-10-28
K112277	Bd Veritor(tm) System for Rapid Detection of Flu A+b	Becton Dickinson & Co	PSZ	Class II	2011-10-28
K112259	Nobelactive 3.0 Goldadapt Abutments	Nobel Biocare AB	NHA	Class II	2011-10-28
K112250	Chx=chx Plus	Inter-Med, Inc.	KJJ	Unclassified	2011-10-28
K112107	Bwiii EEG, Bwiii EEG Plus, Bwiii Psg, Bwiii Psg Plus	Neurovirtual USA, Inc.	GWQ	Class II	2011-10-28
K111988	Easyscan Model 1.2	I-Optics BV	MYC	Class II	2011-10-28
K111693	Philips Heartstart Fr3 Automated External Defibrillator	Philips North America LLC	MKJ	Class III	2011-10-28
K110594	Gf-210R Multi-Gas Module for Nohon Kohden Bedside Monitors	Nihon Kohden Corp.	CCK	Class II	2011-10-28
K110057	Mini Masseuse	Mj Specialty Retail	NGX	Class II	2011-10-28
K103278	Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter; Acura Control Solution	I-SENS, Inc.	CGA	Class II	2011-10-28