Dexcom G6 Continuous Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
by Dexcom, Inc.
Identifiers
- 510(k) Number
- K193642 FDA 510(k)
- FDA Product Code
- QDK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1355 FDA 510(k)
- Regulation Number
- 862.1355 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dexcom G6 Continuous Glucose Monitoring System is an Integrated Continuous Glucose Monitoring System for Non-Intensive Diabetes Management, designed to provide real-time glucose readings for individuals aged two years and older. It functions as a non-invasive, subcutaneous sensor that continuously monitors interstitial glucose levels, transmitting data wirelessly to a compatible receiver or smart device without requiring manual calibration or fingerstick blood glucose checks.
This system is supplied as a reusable receiver paired with single-use sensors, each lasting up to ten days. It operates in compliance with FDA clearance (K193642, Special 510(k)), adhering to regulatory standards for clinical chemistry applications. The device is classified under Device Class II and is intended for non-intensive diabetes management, with no MRI safety restrictions specified. Storage and handling follow standard medical device protocols to maintain sensor integrity and accuracy.
Frequently asked questions
What age group is the Dexcom G6 Continuous Glucose Monitoring System designed for, and how does it differ from other CGM systems in terms of usage?
The Dexcom G6 is designed for individuals aged two years and older, making it suitable for children as well as adults managing non-intensive diabetes care. Unlike some CGM systems that require manual calibration or fingerstick blood glucose checks, the Dexcom G6 provides real-time glucose readings without these steps, offering a more streamlined and non-invasive monitoring experience through a subcutaneous sensor.
How long does a single-use sensor last, and what components of the system are reusable versus single-use?
Each single-use sensor in the Dexcom G6 system lasts up to ten days. The system consists of reusable receivers paired with these disposable sensors, ensuring convenience and cost efficiency over time while maintaining accuracy and reliability.
Does the Dexcom G6 require any special handling or storage conditions to maintain its performance and accuracy?
Yes, the Dexcom G6 sensors and system components should be stored and handled according to standard medical device protocols to preserve sensor integrity and accuracy. While specific storage conditions aren’t detailed in the data, adhering to general guidelines—such as avoiding extreme temperatures or contamination—is recommended to ensure optimal performance.
Can the Dexcom G6 be used in conjunction with other medical devices, and are there any restrictions on its use, such as MRI safety?
The Dexcom G6 is designed for non-intensive diabetes management and does not specify any MRI safety restrictions, meaning it can be used without known interference in non-MRI environments. However, it is not intended for use during MRI procedures, and users should avoid placing the sensor near strong magnetic fields unless explicitly cleared by the manufacturer.
How does the Dexcom G6 transmit glucose data, and what devices are compatible with it for viewing results?
The Dexcom G6 transmits glucose readings wirelessly to a compatible receiver or smart device, eliminating the need for manual data entry. This allows users to monitor their glucose levels in real-time on approved receivers or via Dexcom’s companion mobile apps, which are designed to work seamlessly with the system.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Dexcom G6 Integrated Continuous Glucose Monitoring (CGM) System, Dexcom G6 CGM System | No Fingersticks, No Scanning | Dexcom, Personal or Pro, Dexcom G6 CGM Systems enhances your care., Dexcom G6 CGM System for Personal Use
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193642 | Class II | Active |
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Manufacturer
- Manufacturer
- Dexcom, Inc.
Sources (1)
- FDA 510(k) K193642 24 fields · synced Sep 19, 2026