510(k) Report

Devices descending from K161433

8 later devices reach Insulia Diabetes Management Companion through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171450Glooko Mobile Insulin Dosing SystemGlooko, Inc.20184—
+1K170669Insulia Diabetes Management CompanionVoluntis Sa.201721
+2K193654BlueStar RxWelldoc, Inc.20203—
+2K172177Insulia Diabetes Management CompanionVoluntis Sa.201711
+3K230813BlueStar and BlueStar RxWelldoc, Inc.20230—
+3K203434BlueStar RxWelldoc, Inc.20211—
+3K202596Insulia Diabetes Management CompanionVoluntis Sa.20210—
+4K221924Digital RoutinesGnc Holdings, LLC20230—