510(k) Report

Devices descending from K193371

13 later devices reach FreeStyle Libre 2 Flash Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211102FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.20210—
+1K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc.20219—
+1K202145Bigfoot Unity Diabetes Management SystemBigfoot Biomedical, Inc.202111
+2K222280Bigfoot Unity® Diabetes Management SystemBigfoot Biomedical, Inc.20230—
+2K212132FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.20221Class I
+2K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc.20217—
+3K222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose…Abbott Diabetes Care, Inc.20234—
+3K223537FreeStyle Libre 2 System, FreeStyle Libre 3 SystemAbbott Diabetes Care, Inc.20230—
+3K213996FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.202211
+4K233861Libre Rio Continuous Glucose Monitoring SystemAbbott Diabetes Care20240—
+4K233655Lingo Glucose SystemAbbott20240—
+4K223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…Abbott Diabetes Care, Inc.20231—
+5K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…Abbott Diabetes Care, Inc.20240Class I