510(k) Report

Devices descending from K182630

2 later devices reach Omnipod Insulin Management System, Omnipod DASH Insulin Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation201914
+2K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet Corporation20210Class I