510(k) Report

Devices descending from K193407

5 later devices reach Contour® next GEN Blood Glucose Monitoring System through their predicates, nearest generation first.

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