510(k) Report

Devices descending from K040603

19 later devices reach Paradigm Link Blood Glucose Meter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080639Symphony Glucose Management SystemAnimas Corp.200827
+1K073231Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc.200815—
+2K110587Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control…Bayer Healthcare, LLC20120—
+2K110894Contour Next Link Wireless Blood Glucose MeterBayer Healthcare201213—
+2K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+2K082590Symphony Meter RemoteLifescan, Inc.20080—
+3K122370Contour Next Link Wireless Blood Glucose MonitorBayer Healthcare20133—
+3K121087Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare201210—
+4K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose…Ascensia Diabetes Care U.S., Inc.20162—
+4K150942Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare20159—
+5K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose…Ascensia Diabetes Care20191—
+5K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care20168—
+6K193407Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care202151
+6K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care20210—
+7K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemAscensia Diabetes Care20240—
+7K231476TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring SystemSinocare, Inc.20230—
+7K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.20222—
+8K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…Ascensia Diabetes Care U.S., Inc.20241—
+9K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…Ascensia Diabetes Care20260—