510(k) Report

Devices descending from K222888

2 later devices reach BlueStar CGM insulin dose calculator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252818Dexcom Smart BasalDexcom, Inc.20251—
+2K260062MODI SystemDreaMed Diabetes, Ltd.20260—