510(k) Report

Devices descending from K100066

8 later devices reach Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162532WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc.20175—
+1K162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemWelldoc, Inc.20160—
+1K120558Onetouch Reveal Diabetes Management ApplicationLifescan, Inc.20130—
+2K190013WellDoc BlueStarWelldoc, Inc.20194—
+3K193654BlueStar RxWelldoc, Inc.20203—
+4K230813BlueStar and BlueStar RxWelldoc, Inc.20230—
+4K203434BlueStar RxWelldoc, Inc.20211—
+5K221924Digital RoutinesGnc Holdings, LLC20230—