# K240902: Dexcom G7 Continuous Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Dexcom, Inc.
- Decided: Apr 23, 2024 after 21 days
- Product code: QBJ (Integrated Continuous Glucose Monitoring System, Factory Calibrated)
- Device class: 2
- Regulation: 21 CFR 862.1355
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to DEN170088 (2018). 10 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K234133: Dexcom G7 Continuous Glucose Monitoring System, Dexcom, Inc. (2024) Summary page 4.

## Most influential descendants
- K243214: Dexcom G7 15 Day Continuous Glucose Monitoring System (2025), 3 descendants of its own
- K253737: Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (2026), 1 descendant of its own
- K261402: Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System (2026), 0 descendants of its own
- K253710: Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (2025), 0 descendants of its own

## Recalls of this device
- May 27, 2026 · Class II · Z-2574-2026: Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by 
- Apr 14, 2026 · Class II · Z-2164-2026: A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the b
- Apr 14, 2026 · Class II · Z-2163-2026: A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the b

## Indications for use
The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) 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 purpose of managing diabetes.

Source page: https://510kreport.com/device/K240902
Methodology: https://510kreport.com/methodology