510(k) Report

Devices descending from K024194

83 later devices reach One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082683SD Check GoldStandard Diagnostics, Inc.20096—
+1K082201G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024AU. S. Diagnostics, Inc.20091—
+1K083468Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B…I-Sens, Inc.200921—
+1K080923Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop…I-Sens, Inc.200822—
+1K073030AG-605 Blood Glucose Monitoring SystemAndon Health Co, Ltd.200815—
+1K061431Easygluco, Model Igm-0002 G2U. S. Diagnostics, Inc.20070—
+1K052469GlucopackHealthpia America Corp.20061—
+1K051651G4, Model Igm-0004U. S. Diagnostics, Inc.20060—
+1K052208Glucose PilotTianjin New Bay Bioresearch Co., Ltd.20050—
+1K051285Glucolab Blood Glucose Monitoring SystemInfopia Co, Ltd.20056—
+1K043512Easygluco Igm-0002 G2American Healthcare, Inc.20050—
+1K043543Blood Glucose Monitoring SystemAmerican Healthcare, Inc.20050—
+1K042678Rightest Blood Glucose Monitoring SystemBionime Corporation2005181
+1K040012Well@Home SystemZoe Medical, Inc.200411
+1K031501Easygluco, Model IGM0002American Healthcare, Inc.20030—
+2K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc.20165—
+2K151658Gmate Origin Blood Glucose Monitoring SystemPhilosys, Inc.20150—
+2K141656Gmate Mini Blood Glucose Monitoring System, Gmate Step Blood Glucose Monitoring SystemPhilosys, Inc.20150—
+2K130696Caresens N Link Blood Glucose Monitoring System; Caresens N Link Multi Blood Blucose…I-Sens, Inc.20130—
+2K123007Veri-Q MGD-1001 Blood Glucose Monitoring System, Veri-Q Plus MGD-1001 Blood Glucose…Mico Biomed Co., Ltd.20130—
+2K123016Veri-Q Self-Testing and Veri-Q Plus MGD-2001 Blood Glucose Monitoring SystemsMico Biomed Co., Ltd.20130—
+2K121133Caresens N Voice Blood Glucose Monitoring SystemI-Sens, Inc.20121—
+2K120759Caresens N Mini Blood Glucose Monitoring System, Mini Blood Glucose Meter, Blood Glucose…I-Sens, Inc.20120—
+2K120351Caresens N Pop Blood Glucose Monitoring System Caresens N Pop Blood Glucose Meter…I-Sens, Inc.20120—
+2K103278Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter; Acura…I-Sens, Inc.20112—
+2K103396Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool Control SolutionI-Sens, Inc.20111—
+2K110435Easygluco Plus Blood Glucose Monitoring SystemU. S. Diagnostics, Inc.20110—
+2K101307Blood Glucose Monitoring System, Models AG-6081 and AG-6951Andon Medical Co., Ltd.20111—
+2K093755AG-695 Single and Multi Blood Glucose Monitoring System/AG-696 Single and Multi Blood…Andon Medical Co., Ltd.20110—
+2K093262AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring SystemAndon Medical Co., Ltd.201011—
+2K092052Rightest Blood Glucose Monitoring System, Model GM550Bionime Corporation201010—
+2K100398Smartlink Gold Blood Glucose Monitoring SystemStandard Diagnostics, Inc.20105—
+2K091168Glucophone Blood Glucose Test System, Model Igm-0025Infopia Co, Ltd.20100—
+2K100913Iqvitals and Iqvitals SystemBrentwood Medical Technology Corp.20100—
+2K093475Basesens Blood Glucose Monitoring SystemHygeia, Inc.20100—
+2K091157Gluco Lab Auto Coding, Model Igm-0022Infopia Co, Ltd.20092—
+2K090712Eocene SystemInfopia Co, Ltd.20090—
+2K080636Duo-Max Blood Pressure & Glucose Monitor HMF-100Hubdic Co., Ltd.20090—
+2K081451Rightest Blood Glucose Monitoring System, Model GM100Bionime Corporation20082—
+2K081450Rightest Blood Glucose Monitoring System, Model GM110Bionime Corporation20080—
+2K072054Rightest Blood Glucose Monitoring System, Model GM310Bionime Corporation20080—
+2K062567Rightest Blood Glucose Monitoring SystemBionime Corporation2007161
+2K053635Modification to Rightest Blood Glucose Monitoring SystemBionime Corporation2006171
+3K171480NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemI-Sens, Inc.20170—
+3K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose…I-Sens, Inc.20173—
+3K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor20170—
+3K132929SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor…Sd Biosensor, Inc.20151—
+3K143387GE333 Blood Glucose Monitoring SystemBionime Coporation20153—
+3K133522Rightest Diabetes Management Software and Adapter (Existing Cleared K113007),Rightest…Bionime Coporation20140—
+3K123517Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring…Sd Biosensor20141—
+3K132288Caresens N Voice Multi Blood Glucose Monitoring System, Caresens N Voice Multi Blood…I-Sens, Inc.20130—
+3K131419Acura Plus Multi Blood Glucose Monitoring SystemI-Sens, Inc.20131—
+3K102751Labonacheck Gluppy Blood Glucose Monitoring SystemCeragem Medisys, Inc.20131—
+3K121654Auto-Chek Blood Glucose Monitoring System, Meter, Test Strip. Auto-Check Control SolutionI-Sens, Inc.20120—
+3K120921Clever ChoiceSimple Diagnostics, Inc.20120—
+3K120423Bionime Rightest Blood Glucose Monitoring System, Model GM650Bionime Corporation20123—
+3K113192Healthpro Blood Glucose Monitoring SystemInfopia Co, Ltd.20121—
+3K110737Rightest Blood Glucose Monitoring System GM700Bionime Corporation20124—
+3K110017AG-608N Blood Glucose Monitoring SystemAndon Medical Co., Ltd.201210—
+4K230625ReliOn Premier BLU Blood Glucose Monitoring SystemI-Sens, Inc.20230—
+4K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood…I-Sens, Inc.20180—
+4K180866CareSens S Fit Blood Glucose Monitoring SystemI-Sens, Inc.20180—
+4K170143GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest…Bionime Corporation20171—
+4K161790iGlucose Blood Glucose Monitoring SystemBionime Corporation20170—
+4K153561AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring SystemAndon Health Co, Ltd.20170—
+4K153201SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi…Sd Biosensor20160—
+4K151265SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring…Sd Biosensor20150—
+4K151164Assure Prism multi Blood Glucose Monitoring SystemI-Sens, Inc.20150—
+4K141292Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System…Bionime Coporation20150—
+4K140141Labonacheck Gluppy Blood Glucose Monitoring SystemCeragem Medisys, Inc.20140—
+4K132180Ideal Life Gluco-Manager Blood Glucose Monitoring SystemIdeal Life, Inc.20140—
+4K132862Healthpro Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.20130—
+4K133003Rightest Control SolutionBionime Corporation20130—
+4K123935Ihealth BG5/BG5L Wireless Smart Glucose Monitoring SystemAndon Medical Co., Ltd.20133—
+4K123008Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose Monitoring System…Bionime Corporation20132—
+4K120813Blood Glucose Monitoring SystemAndon Medical Co., Ltd.20127—
+5K173139Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System…Bionime Corporation20180—
+5K153278Wireless Smart Gluco-Monitoring SystemAndon Health Co, Ltd.20162—
+5K133790Ihealth Align Mini Gluco-Monitoring SystemAndon Health Co, Ltd.20142—
+6K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring…Andon Health Co, Ltd.20171—
+6K153286iHealth Align Gluco-Monitoring systemAndon Health Co, Ltd.20160—
+6K150833iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring…Andon Health Co, Ltd.20150—
+7K181070iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)Andon Health Co, Ltd.20190—