Medical Device Manufacturer · US , San Diego , CA

Dexcom, Inc. - FDA 510(k) Cleared Devices

24 submissions · 21 cleared · Since 2014
24
Total
21
Cleared
3
Denied

FDA 510(k) cleared devices by Dexcom, Inc. Chemistry

22 devices
1-22 of 22
Cleared Feb 03, 2026
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K253737 · QBJ
Chemistry · 71d
Cleared Dec 17, 2025
Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day...
K253710 · QBJ
Chemistry · 23d
Cleared Nov 18, 2025
Dexcom Smart Basal
K252818 · QRX
Chemistry · 75d
Cleared Apr 09, 2025
Dexcom G7 15 Day Continuous Glucose Monitoring System
K243214 · QBJ
Chemistry · 188d
Cleared Mar 05, 2024
Stelo Glucose Biosensor System
K234070 · SAF
Chemistry · 74d
Cleared May 15, 2023
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K231081 · QBJ
Chemistry · 28d
Cleared Jan 11, 2023
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K223931 · QBJ
Chemistry · 12d
Cleared Dec 07, 2022
Dexcom G7 Continuous Glucose Monitoring System
K213919 · QBJ
Chemistry · 357d
Cleared Jul 29, 2022
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose...
K221259 · QBJ
Chemistry · 88d
Cleared Aug 17, 2021
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K203089 · QDK
Chemistry · 308d
Cleared Jul 15, 2021
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K201328 · QBJ
Chemistry · 422d
Cleared Dec 04, 2020
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program...
K200876 · QBJ
Chemistry · 247d
Cleared Jan 29, 2020
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K193642 · QDK
Chemistry · 30d
Cleared Oct 25, 2019
Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
K192787 · QDK
Chemistry · 25d
Cleared Oct 07, 2019
Dexcom G6 Pro Continuous Glucose Monitoring System
K191833 · QII
Chemistry · 90d
Cleared Jun 28, 2019
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program...
K191450 · QBJ
Chemistry · 28d
Cleared Feb 14, 2019
Dexcom G6 Continuous Glucose Monitoring System
K183206 · QBJ
Chemistry · 87d
Cleared Nov 02, 2018
Dexcom Pro Q Continuous Glucose Monitoring System
K182405 · QDL
Chemistry · 59d
Cleared Oct 26, 2018
Dexcom G6 Glucose Program Continuous Glucose Monitoring System
K182041 · QDK
Chemistry · 88d
Not Cleared Mar 27, 2018
Dexcom G6 Continuous Glucose Monitoring System
DEN170088 · QBJ
Chemistry · 109d
Not Cleared Jan 23, 2015
Dexcom Share Direct Secondary Displays
DEN140038 · PJT
Chemistry · 39d
Not Cleared Aug 19, 2014
STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
DEN140016 · PHV
Chemistry · 119d
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