# K201328: Dexcom G6 Continuous Glucose Monitoring (CGM) System

- Pathway: 510(k) (Traditional)
- Applicant: Dexcom, Inc.
- Decided: Jul 15, 2021 after 422 days
- Product code: QBJ (Integrated Continuous Glucose Monitoring System, Factory Calibrated)
- Device class: 2
- Regulation: 21 CFR 862.1355
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN170088 (2018). 6 ancestors in all.
15 later devices descend from it; 2 cite it directly.
2 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200876: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System, Dexcom, Inc. (2020). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K213919: Dexcom G7 Continuous Glucose Monitoring System (2022), 12 descendants of its own
- K231081: Dexcom G7 Continuous Glucose Monitoring (CGM) System (2023), 11 descendants of its own
- K234133: Dexcom G7 Continuous Glucose Monitoring System (2024), 5 descendants of its own
- K240902: Dexcom G7 Continuous Glucose Monitoring System (2024), 4 descendants of its own
- K234070: Stelo Glucose Biosensor System (2024), 4 descendants of its own

## Indications for use
The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older. The Dexcom G6 System is intended to replace fmgerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

Source page: https://510kreport.com/device/K201328
Methodology: https://510kreport.com/methodology