510(k) Report

Devices descending from K203768

2 later devices reach Omnipod 5 ACE Pump (Pod) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231826Omnipod 5 ACE PumpInsulet Corporation20231Class I
+2K260001Mint ACE PumpBeta Bionics, Inc.20260—