510(k) Report

Devices descending from K122953

8 later devices reach Omnipod Insulin Managment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162296OmniPod Insulin Management SystemInsulet Corporation20174—
+1K160252OmniPod Insulin Management SystemInsulet Corporation20160—
+1K140439Omnipod Insulin Management SystemInsulet Corporation20140—
+1K131294Omnipod Insulin Management SystemInsulet Corporation20130—
+2K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation20192—
+2K180045Omnipod DASH Insulin Management SystemInsulet Corporation201831
+3K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation201914
+4K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet Corporation20210Class I