510(k) Report

Devices descending from K030531

20 later devices reach Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080639Symphony Glucose Management SystemAnimas Corp.200827
+1K040603Paradigm Link Blood Glucose MeterBecton, Dickinson & CO200419—
+2K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+2K082590Symphony Meter RemoteLifescan, Inc.20080—
+2K073231Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc.200815—
+3K110587Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control…Bayer Healthcare, LLC20120—
+3K110894Contour Next Link Wireless Blood Glucose MeterBayer Healthcare201213—
+4K122370Contour Next Link Wireless Blood Glucose MonitorBayer Healthcare20133—
+4K121087Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare201210—
+5K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose…Ascensia Diabetes Care U.S., Inc.20162—
+5K150942Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare20159—
+6K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose…Ascensia Diabetes Care20191—
+6K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care20168—
+7K193407Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care202151
+7K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care20210—
+8K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemAscensia Diabetes Care20240—
+8K231476TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring SystemSinocare, Inc.20230—
+8K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.20222—
+9K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…Ascensia Diabetes Care U.S., Inc.20241—
+10K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…Ascensia Diabetes Care20260—