510(k) Report

Devices descending from DEN170043

10 later devices reach DreaMed Advisor Pro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191370DreaMed Advisor ProDreaMed Diabetes, Ltd.20199—
+2K201476DreaMed Advisor ProDreaMed Diabetes, Ltd.20208—
+3K203772Omnipod 5 SmartBolus CalculatorInsulet Corporation20225—
+3K210561Advisor Pro PlatformDreaMed Diabetes, Ltd.20211—
+4K232722endo.digital PlatformDreaMed Diabetes, Ltd.20230—
+4K222888BlueStar CGM insulin dose calculatorWelldoc, Inc.20232—
+4K222239SmartBolus CalculatorInsulet Corporation20221—
+5K252818Dexcom Smart BasalDexcom, Inc.20251—
+5K231824SmartBolus CalculatorInsulet Corporation20230—
+6K260062MODI SystemDreaMed Diabetes, Ltd.20260—