510(k) Report

Devices descending from K160682

8 later devices reach CONTOUR NEXT ONE Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193407Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care202151
+1K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose…Ascensia Diabetes Care20191—
+2K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemAscensia Diabetes Care20240—
+2K231476TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring SystemSinocare, Inc.20230—
+2K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.20222—
+2K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care20210—
+3K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…Ascensia Diabetes Care U.S., Inc.20241—
+4K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…Ascensia Diabetes Care20260—