510(k) Report

Devices descending from K210943

7 later devices reach FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose…Abbott Diabetes Care, Inc.20234—
+1K223537FreeStyle Libre 2 System, FreeStyle Libre 3 SystemAbbott Diabetes Care, Inc.20230—
+1K213996FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.202211
+2K233861Libre Rio Continuous Glucose Monitoring SystemAbbott Diabetes Care20240—
+2K233655Lingo Glucose SystemAbbott20240—
+2K223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…Abbott Diabetes Care, Inc.20231—
+3K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…Abbott Diabetes Care, Inc.20240Class I