Medical Device Manufacturer · US , San Diego , CA

Dexcom, Inc.

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

Dexcom, Inc. — FDA 510(k) Submissions

Dexcom, Inc. has submitted 24 FDA 510(k) premarket notifications since 2014, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Integrated Continuous Glucose Monitoring System, Factory Calibrated, Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management, Continuous Glucose Monitor Informed Insulin Dose Calculator, Continuous Glucose Monitor Retrospective Data Analysis Software, Continuous Glucose Monitor Secondary Display . Use the specialty filter in the sidebar to narrow results.

24 devices
1–24 of 24
Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
K253737 · QBJ Integrated Continuous... · Chemistry
Feb 2026 71d
Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
K253710 · QBJ Integrated Continuous... · Chemistry
Dec 2025 23d
Dexcom Smart Basal
K252818 · QRX Continuous Glucose... · Chemistry
Nov 2025 75d
Dexcom G7 15 Day Continuous Glucose Monitoring System
K243214 · QBJ Integrated Continuous... · Chemistry
Apr 2025 188d
Dexcom G7 Continuous Glucose Monitoring System
K240902 · QBJ Integrated Continuous... · General & Plastic Surgery
Apr 2024 21d
Stelo Glucose Biosensor System
K234070 · SAF Integrated Continuous... · Chemistry
Mar 2024 74d
Dexcom G7 Continuous Glucose Monitoring System
K234133 · QBJ Integrated Continuous... · General & Plastic Surgery
Feb 2024 59d
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K231081 · QBJ Integrated Continuous... · Chemistry
May 2023 28d
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K223931 · QBJ Integrated Continuous... · Chemistry
Jan 2023 12d
Dexcom G7 Continuous Glucose Monitoring System
K213919 · QBJ Integrated Continuous... · Chemistry
Dec 2022 357d
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System
K221259 · QBJ Integrated Continuous... · Chemistry
Jul 2022 88d
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K203089 · QDK Integrated Continuous... · Chemistry
Aug 2021 308d
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K201328 · QBJ Integrated Continuous... · Chemistry
Jul 2021 422d
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System
K200876 · QBJ Integrated Continuous... · Chemistry
Dec 2020 247d
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K193642 · QDK Integrated Continuous... · Chemistry
Jan 2020 30d
Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
K192787 · QDK Integrated Continuous... · Chemistry
Oct 2019 25d
Dexcom G6 Pro Continuous Glucose Monitoring System
K191833 · QII Integrated Continuous... · Chemistry
Oct 2019 90d
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System
K191450 · QBJ Integrated Continuous... · Chemistry
Jun 2019 28d
Dexcom G6 Continuous Glucose Monitoring System
K183206 · QBJ Integrated Continuous... · Chemistry
Feb 2019 87d
Dexcom Pro Q Continuous Glucose Monitoring System
K182405 · QDL Integrated Continuous... · Chemistry
Nov 2018 59d
Dexcom G6 Glucose Program Continuous Glucose Monitoring System
K182041 · QDK Integrated Continuous... · Chemistry
Oct 2018 88d
Dexcom G6 Continuous Glucose Monitoring System
DEN170088 · QBJ Integrated Continuous... · Chemistry
Mar 2018 109d
Dexcom Share Direct Secondary Displays
DEN140038 · PJT Continuous Glucose... · Chemistry
Jan 2015 39d
STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
DEN140016 · PHV Continuous Glucose... · Chemistry
Aug 2014 119d
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