# K231081: Dexcom G7 Continuous Glucose Monitoring (CGM) System

- Pathway: 510(k) (Special)
- Applicant: Dexcom, Inc.
- Decided: May 15, 2023 after 28 days
- Product code: QBJ (Integrated Continuous Glucose Monitoring System, Factory Calibrated)
- Device class: 2
- Regulation: 21 CFR 862.1355
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN170088 (2018). 8 ancestors in all.
11 later devices descend from it; 2 cite it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213919: Dexcom G7 Continuous Glucose Monitoring System, Dexcom, Inc. (2022) Summary page 4.

## Most influential descendants
- 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
- K243214: Dexcom G7 15 Day Continuous Glucose Monitoring System (2025), 3 descendants of its own
- K260935: Stelo Glucose Biosensor System (2026), 1 descendant of its own

## Recalls of this device
- May 5, 2025 · Class II · Z-1906-2025: A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware t

## Indications for use
The Dexcom G7 Continuous Glucose Monitoring (CGM) System is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older. The Dexcom G7 CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G7 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purposes of managing diabetes.

Source page: https://510kreport.com/device/K231081
Methodology: https://510kreport.com/methodology