510(k) Report

Devices descending from K111669

9 later devices reach Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122953Omnipod Insulin Managment SystemInsulet Corporation20128Class I
+2K162296OmniPod Insulin Management SystemInsulet Corporation20174—
+2K160252OmniPod Insulin Management SystemInsulet Corporation20160—
+2K140439Omnipod Insulin Management SystemInsulet Corporation20140—
+2K131294Omnipod Insulin Management SystemInsulet Corporation20130—
+3K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation20192—
+3K180045Omnipod DASH Insulin Management SystemInsulet Corporation201831
+4K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation201914
+5K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet Corporation20210Class I