510(k) Report

Devices descending from K203772

5 later devices reach Omnipod 5 SmartBolus Calculator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222888BlueStar CGM insulin dose calculatorWelldoc, Inc.20232—
+1K222239SmartBolus CalculatorInsulet Corporation20221—
+2K252818Dexcom Smart BasalDexcom, Inc.20251—
+2K231824SmartBolus CalculatorInsulet Corporation20230—
+3K260062MODI SystemDreaMed Diabetes, Ltd.20260—