# K223931: Dexcom G6 Continuous Glucose Monitoring (CGM) System

- Pathway: 510(k) (Special)
- Applicant: Dexcom, Inc.
- Decided: Jan 11, 2023 after 12 days
- Product code: QBJ (Integrated Continuous Glucose Monitoring System, Factory Calibrated)
- Device class: 2
- Regulation: 21 CFR 862.1355
- Recalls of this device: 5 (2 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). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221259: Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System, Dexcom, Inc. (2022) Summary page 4.

## Recalls of this device
- Aug 28, 2025 · Class I · Z-0318-2026: A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notificat
- May 12, 2025 · Class I · Z-1943-2025: Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audib
- Jan 27, 2025 · Class II · Z-1203-2025: Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operati
- Jan 27, 2025 · Class II · Z-1202-2025: Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operati
- Jan 27, 2025 · Class II · Z-1204-2025: Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operati

## 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 fingerstick 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/K223931
Methodology: https://510kreport.com/methodology