# K182405: Dexcom Pro Q Continuous Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Dexcom, Inc.
- Decided: Nov 2, 2018 after 59 days
- Product code: QDL (Integrated Continuous Glucose Monitoring System For Professional Retrospective Use)
- 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: 1 generation back to DEN170088 (2018). 1 ancestor in all.
22 later devices descend from it; 1 cites it directly.
2 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170088: Dexcom G6 Continuous Glucose Monitoring System, Dexcom, Inc. (2018) Summary page 6.

## Most influential descendants
- K191450: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System (2019), 21 descendants of its own
- 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

## Indications for use
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/K182405
Methodology: https://510kreport.com/methodology