510(k) Report

Devices descending from K042792

15 later devices reach Ixl-II Diabetes Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122953Omnipod Insulin Managment SystemInsulet Corporation20128Class I
+1K111669Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management SystemsInsulet Corporation20119—
+1K093364Solo Micropump Insulin Delivery SystemMedingo, Ltd.20100—
+1K090245Solo Insulin Patch PumpMedingo, Ltd.20091—
+1K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+1K080639Symphony Glucose Management SystemAnimas Corp.200827
+2K162296OmniPod Insulin Management SystemInsulet Corporation20174—
+2K160252OmniPod Insulin Management SystemInsulet Corporation20160—
+2K140439Omnipod Insulin Management SystemInsulet Corporation20140—
+2K131294Omnipod Insulin Management SystemInsulet Corporation20130—
+2K082590Symphony Meter RemoteLifescan, Inc.20080—
+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