510(k) Report

Devices descending from K091820

18 later devices reach Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110894Contour Next Link Wireless Blood Glucose MeterBayer Healthcare201213—
+1K113007Bionime Diabetes Management System VI.0Bionime Corporation20121—
+1K101371ON Call Plus Diabetes Monitoring SoftwareACON Laboratories, Inc.20111—
+2K133584IN Touch Blood Glucose Monitoring SystemEoshealth, Inc.201401
+2K133522Rightest Diabetes Management Software and Adapter (Existing Cleared K113007),Rightest…Bionime Coporation20140—
+2K122370Contour Next Link Wireless Blood Glucose MonitorBayer Healthcare20133—
+2K121087Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare201210—
+3K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose…Ascensia Diabetes Care U.S., Inc.20162—
+3K150942Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare20159—
+4K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose…Ascensia Diabetes Care20191—
+4K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care20168—
+5K193407Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care202151
+5K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care20210—
+6K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemAscensia Diabetes Care20240—
+6K231476TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring SystemSinocare, Inc.20230—
+6K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.20222—
+7K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…Ascensia Diabetes Care U.S., Inc.20241—
+8K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…Ascensia Diabetes Care20260—