510(k) Report

Devices descending from K043529

10 later devices reach Accu-Chek Advisor Insulin Guidance Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103643Ascot Home Medical Monitoring System (HMMS)Ascot Technologies, Inc.20110—
+1K100066Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1Welldoc, Inc.20108—
+2K162532WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc.20175—
+2K162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemWelldoc, Inc.20160—
+2K120558Onetouch Reveal Diabetes Management ApplicationLifescan, Inc.20130—
+3K190013WellDoc BlueStarWelldoc, Inc.20194—
+4K193654BlueStar RxWelldoc, Inc.20203—
+5K230813BlueStar and BlueStar RxWelldoc, Inc.20230—
+5K203434BlueStar RxWelldoc, Inc.20211—
+6K221924Digital RoutinesGnc Holdings, LLC20230—