510(k) Report

Devices descending from K162296

4 later devices reach OmniPod Insulin Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation20192—
+1K180045Omnipod DASH Insulin Management SystemInsulet Corporation201831
+2K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation201914
+3K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet Corporation20210Class I