510(k) Report

Devices descending from K062395

10 later devices reach Accu-Chek Smart Pix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080227Accu-Chek 360 Diabetes Management SystemRoche Diagnostics Corp.20089—
+2K100066Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1Welldoc, Inc.20108—
+3K162532WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc.20175—
+3K162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemWelldoc, Inc.20160—
+3K120558Onetouch Reveal Diabetes Management ApplicationLifescan, Inc.20130—
+4K190013WellDoc BlueStarWelldoc, Inc.20194—
+5K193654BlueStar RxWelldoc, Inc.20203—
+6K230813BlueStar and BlueStar RxWelldoc, Inc.20230—
+6K203434BlueStar RxWelldoc, Inc.20211—
+7K221924Digital RoutinesGnc Holdings, LLC20230—