# K192787: Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System

- Pathway: 510(k) (Special)
- Applicant: Dexcom, Inc.
- Decided: Oct 25, 2019 after 25 days
- Product code: QDK (Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management)
- 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: 3 generations back to DEN170088 (2018). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191450: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System, Dexcom, Inc. (2019) Summary page 5.

## Most influential descendants
- K193642: Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System (2020), 0 descendants of its own

## Indications for use
The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older. The Dexcom Glucose Program System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions for persons with diabetes who are not at significant risk of severe hypoglycemia. Interpretation of the Dexcom Glucose Program System results should be based on the glucose trends and several sequential readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The Dexcom Glucose Program System is also intended to autonomously communicate with digitally connected devices. The Dexcom Glucose Program System can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.

Source page: https://510kreport.com/device/K192787
Methodology: https://510kreport.com/methodology