510(k) Report

Devices descending from K150910

32 later devices reach ACCU-CHEK Connect Diabetes Management App through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213131Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemRoche Diabetes Care GmbH20230—
+1K161433Insulia Diabetes Management CompanionVoluntis Sa.20168—
+1K160629InPenCompanion Medical, Inc.2016211
+2K222689Mallya Injection Pen Adapter (Mallya® for Solostar®)Biocorp Production20224—
+2K212217Tempo Smart ButtonEli Lilly and Company20221—
+2K190487InPen Dose CalculatorCompanion Medical, Inc.2020101
+2K192841InPen SystemCompanion Medical, Inc.202001
+2K181327InPen Dose CalculatorCompanion Medical, Inc.20181—
+2K171450Glooko Mobile Insulin Dosing SystemGlooko, Inc.20184—
+2K170669Insulia Diabetes Management CompanionVoluntis Sa.201721
+3K243901SmartPilot YpsoMate NS-A2.25Ypsomed AG20250—
+3K252104T1D1Comerge AG20250—
+3K241803INSULCLOCK® v2.0 PROInsulcloud S.L.20240—
+3K231820SoloSmart Injection Pen Adapter (SoloSmart®)Biocorp Production20242—
+3K232451Insulia Bolus CompanionVoluntis Sa.20230—
+3K201337InPen SystemCompanion Medical, Inc.202072
+3K193654BlueStar RxWelldoc, Inc.20203—
+3K193483Basal-IQ TechnologyTandem Diabetes Care, Inc.20200Class I
+3K172177Insulia Diabetes Management CompanionVoluntis Sa.201711
+4K250555MallyaD injection pen adapter (MallyaD)Biocorp Production20251—
+4K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed202463
+4K230813BlueStar and BlueStar RxWelldoc, Inc.20230—
+4K203434BlueStar RxWelldoc, Inc.20211—
+4K202596Insulia Diabetes Management CompanionVoluntis Sa.20210—
+5K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.20260—
+5K253512MiniMed Go AppMedtronic Minimed202602
+5K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc.202546
+5K251500MallyaG Injection Pen Adapter (MallyaG)Biocorp Production20250—
+5K221924Digital RoutinesGnc Holdings, LLC20230—
+6K253743MiniMed Flex pumpMedtronic Minimed, Inc.202601
+6K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed20261—
+7K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed20260—