510(k) Report

Devices descending from DEN170088

39 later devices reach Dexcom G6 Continuous Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193371FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.202013Class I
+1K183206Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc.201922—
+1K182405Dexcom Pro Q Continuous Glucose Monitoring SystemDexcom, Inc.201822—
+1K182041Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc.201822—
+2K211102FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.20210—
+2K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc.20219—
+2K202145Bigfoot Unity Diabetes Management SystemBigfoot Biomedical, Inc.202111
+2K191450Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous…Dexcom, Inc.2019212
+3K222280Bigfoot Unity® Diabetes Management SystemBigfoot Biomedical, Inc.20230—
+3K212132FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.20221Class I
+3K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc.20217—
+3K200876Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous…Dexcom, Inc.2020171
+3K192787Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) SystemDexcom, Inc.20191—
+3K191833Dexcom G6 Pro Continuous Glucose Monitoring SystemDexcom, Inc.20192—
+4K222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose…Abbott Diabetes Care, Inc.20234—
+4K223537FreeStyle Libre 2 System, FreeStyle Libre 3 SystemAbbott Diabetes Care, Inc.20230—
+4K221259Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program…Dexcom, Inc.20221—
+4K213996FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.202211
+4K203089Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.20212—
+4K201328Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.202115—
+4K193642Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.20200—
+5K233861Libre Rio Continuous Glucose Monitoring SystemAbbott Diabetes Care20240—
+5K233655Lingo Glucose SystemAbbott20240—
+5K223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…Abbott Diabetes Care, Inc.20231—
+5K223931Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.20230Class I
+5K213919Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc.202212Class I
+6K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…Abbott Diabetes Care, Inc.20240Class I
+6K231081Dexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.2023111
+7K234070Stelo Glucose Biosensor SystemDexcom, Inc.20244—
+7K234133Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc.20245—
+8K260935Stelo Glucose Biosensor SystemDexcom, Inc.20261—
+8K261359Stelo Glucose Biosensor SystemDexcom, Inc.20260—
+8K250106Signos Glucose Monitoring SystemSignos, Inc.20250—
+8K240902Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc.202443
+9K262472Stelo Glucose Biosensor SystemDexcom, Inc.20260—
+9K253737Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous…Dexcom, Inc.20261—
+9K253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous…Dexcom, Inc.20250—
+9K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemDexcom, Inc.202532
+10K261402Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose…Dexcom, Inc.20260—