510(k) Report

Devices descending from K043197

6 later devices reach Onetouch Ultra, Induo and Ultrasmart Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080639Symphony Glucose Management SystemAnimas Corp.200827
+1K062555Ebsensor Blood Glucose Monitoring System, Model EB-GVisgeneer, Inc.20062—
+2K122181Ebchek Blood Glucose Monitoring SystemVisgeneer, Inc.20130—
+2K091765Ebcarryon Blood Glucose Monitoring SystemVisgeneer, Inc.20100—
+2K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+2K082590Symphony Meter RemoteLifescan, Inc.20080—