510(k) Report

Devices descending from K043474

63 later devices reach Accu-Chek Aviva System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160944ACCU-CHEK Guide Blood Glucose Monitoring SystemRoche Diabetes Care, Inc.201632
+1K123612Fdi Glucose Control Solution for Use with Accu-Chek AvivaFujirebio Diagnostics,Inc.20130—
+1K121679Accu-Chek Inform II Blood Glucose Monitoring SystemRoche Diagnostics201253
+1K101299Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics201144—
+1K110436Fdi Glucose Control Solution for AvivaFujirebio Diagnostics,Inc.20110—
+1K082965DS-a Blood Glucose Monitoring SystemAlliance International Co., Ltd.20091—
+1K083628Glucodr Auto SystemAll Medicus Co., Ltd.20091—
+1K082328Glucodr Plus System, Model Agm-3000All Medicus Co., Ltd.20090—
+1K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc.20082—
+1K060620Accu-Chek Aviva Test StripsRoche Diagnostics Corp.2006461
+2K213131Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemRoche Diabetes Care GmbH20230—
+2K203711IWL2020 Blood Glucose Monitoring SystemRoche Diabetes Care, Inc.20220—
+2K181131Accu-Chek Guide Me Blood Glucose Monitoring SystemRoche Diabetes Care20180—
+2K170241GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring…All Medicus Co., Ltd.20170—
+2K132663I-Qare DS-W Blood Glucose Monitoring SystemAlliance International Co., Ltd.20150—
+2K133741ACCU-CHEK Performa Blood Glucose Monitoring SystemRoche Diagnostics201431
+2K133862Accu-Chek Aviva Plus SystemRoche Diagnostics Corporation201452
+2K131029Accu-Chek Aviva Plus Test StripRoche Diagnostics Operations, Inc.201306
+2K130138Super Sani-Cloth/ Accu-Chek Inform II SystemRoche Diagnostics Corp.20130—
+2K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc.20131—
+2K111353Accu-Check Combo SystemRoche Diagnostics2012373
+2K113137Glucose Test SystemRoche Diagnostics201203
+2K071493Clever Chek TD-4209 Blood Glucose Monitoring System, Model TD-4209, TD-4222, TD-4225Taidoc Technology Corporation20070—
+3K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose…Tyson Bioresearch, Inc.20172—
+3K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20160—
+3K141929Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation2015331
+3K141867Accu-Chek Aviva Connect Blood Glucose Monitoring SystemRoche Diagnostics20154—
+3K131366Accu-Chek Aviva Expert Blood Glucose Monitoring SystemRoche Diagnostics Operations, Inc.20131—
+4K182046Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose…Tyson Bioresearch, Inc.20180—
+4K182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose…Tyson Bioresearch, Inc.20180—
+4K150910ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc.2015326
+4K142089Accu-Chek Aviva Expert SystemRoche Diagnostics Corporation20140—
+5K161433Insulia Diabetes Management CompanionVoluntis Sa.20168—
+5K160629InPenCompanion Medical, Inc.2016211
+6K222689Mallya Injection Pen Adapter (Mallya® for Solostar®)Biocorp Production20224—
+6K212217Tempo Smart ButtonEli Lilly and Company20221—
+6K190487InPen Dose CalculatorCompanion Medical, Inc.2020101
+6K192841InPen SystemCompanion Medical, Inc.202001
+6K181327InPen Dose CalculatorCompanion Medical, Inc.20181—
+6K171450Glooko Mobile Insulin Dosing SystemGlooko, Inc.20184—
+6K170669Insulia Diabetes Management CompanionVoluntis Sa.201721
+7K243901SmartPilot YpsoMate NS-A2.25Ypsomed AG20250—
+7K252104T1D1Comerge AG20250—
+7K241803INSULCLOCK® v2.0 PROInsulcloud S.L.20240—
+7K231820SoloSmart Injection Pen Adapter (SoloSmart®)Biocorp Production20242—
+7K232451Insulia Bolus CompanionVoluntis Sa.20230—
+7K201337InPen SystemCompanion Medical, Inc.202072
+7K193654BlueStar RxWelldoc, Inc.20203—
+7K193483Basal-IQ TechnologyTandem Diabetes Care, Inc.20200Class I
+7K172177Insulia Diabetes Management CompanionVoluntis Sa.201711
+8K250555MallyaD injection pen adapter (MallyaD)Biocorp Production20251—
+8K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed202463
+8K230813BlueStar and BlueStar RxWelldoc, Inc.20230—
+8K203434BlueStar RxWelldoc, Inc.20211—
+8K202596Insulia Diabetes Management CompanionVoluntis Sa.20210—
+9K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.20260—
+9K253512MiniMed Go AppMedtronic Minimed202602
+9K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc.202546
+9K251500MallyaG Injection Pen Adapter (MallyaG)Biocorp Production20250—
+9K221924Digital RoutinesGnc Holdings, LLC20230—
+10K253743MiniMed Flex pumpMedtronic Minimed, Inc.202601
+10K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed20261—
+11K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed20260—