# K191450: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Dexcom, Inc.
- Decided: Jun 28, 2019 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170088 (2018). 4 ancestors in all.
21 later devices descend from it; 3 cite it directly.
2 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183206: Dexcom G6 Continuous Glucose Monitoring System, Dexcom, Inc. (2019) Summary page 7.
- K182041: Dexcom G6 Glucose Program Continuous Glucose Monitoring System, Dexcom, Inc. (2018) Summary page 7.
- K182405: Dexcom Pro Q Continuous Glucose Monitoring System, Dexcom, Inc. (2018) Summary page 7.

## Most influential descendants
- K200876: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System (2020), 17 descendants of its own
- K201328: Dexcom G6 Continuous Glucose Monitoring (CGM) System (2021), 15 descendants of its own
- K213919: Dexcom G7 Continuous Glucose Monitoring System (2022), 12 descendants of its own
- 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

## Recalls of this device
- Feb 3, 2020 · Class II · Z-1562-2020: The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.
- Nov 19, 2019 · Class II · Z-1104-2020: It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iO

## 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. 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. The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a factory calibrated continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 years and older under the supervision of a healthcare professional. The Dexcom Pro Q System collects and processes data for aiding in the management of a disease or condition related to glycemic control. Interpretation of the data recorded by the Dexcom Pro Q System results should be made only by a qualified healthcare professional based on glucose trends and several sequential readings over time. The Dexcom Pro Q System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom Pro Q System is also intended to interface with digitally connected devices.

Source page: https://510kreport.com/device/K191450
Methodology: https://510kreport.com/methodology