# K213919: Dexcom G7 Continuous Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Dexcom, Inc.
- Decided: Dec 7, 2022 after 357 days
- Product code: QBJ (Integrated Continuous Glucose Monitoring System, Factory Calibrated)
- Device class: 2
- Regulation: 21 CFR 862.1355
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN170088 (2018). 7 ancestors in all.
12 later devices descend from it; 1 cites 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)
- K201328: Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom, Inc. (2021) Summary page 5.

## Most influential descendants
- 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
- K243214: Dexcom G7 15 Day Continuous Glucose Monitoring System (2025), 3 descendants of its own

## Recalls of this device
- Jul 24, 2025 · Class I · Z-2448-2025: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS an
- Jul 24, 2025 · Class I · Z-2447-2025: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS an
- Jul 24, 2025 · Class I · Z-2446-2025: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS an
- May 12, 2025 · Class I · Z-1944-2025: 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

## 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/K213919
Methodology: https://510kreport.com/methodology