510(k) Report

Devices descending from K111268

6 later devices reach Contour (R) Next Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130265Contour Next EZ Blood Glucose MeterBayer Healthcare, LLC20145—
+2K162203POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20171—
+2K162336Contour Next EZ Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.20172—
+3K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose…Ascensia Diabetes Care20191—
+3K181316POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20180—
+4K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care20210—