Dexcom G6 Glucose Program Continuous Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
by Dexcom, Inc.
Identifiers
- 510(k) Number
- K182041 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 Glucose Program Continuous Glucose Monitoring System is an Integrated Continuous Glucose Monitoring System for Non-Intensive Diabetes Management, as classified by the FDA. It provides real-time, continuous glucose readings via a subcutaneous sensor, eliminating the need for fingerstick blood glucose tests. The system is designed to offer patients with diabetes—ages two and older—ongoing glucose trend data, alarms for high or low glucose levels, and integration with external devices for enhanced diabetes management. Its non-invasive approach supports improved glycemic control and user autonomy.
The system is supplied as a reusable transmitter paired with single-use sensors, which are applied to the skin and worn for up to ten days. It is intended for home use and does not require sterilization beyond standard skin preparation before sensor application. The device operates independently of MRI environments but must be removed prior to MRI procedures due to its electronic components. Authorized under FDA 510(k) clearance (K182041) as substantially equivalent, it adheres to regulatory standards for Class II medical devices under 21 CFR 862.1355. No additional regulatory markings or certifications are specified beyond the stated FDA clearance.
Frequently asked questions
What is the Dexcom G6 Glucose Program Continuous Glucose Monitoring System used for?
The Dexcom G6 is designed for non-intensive diabetes management in patients aged two and older. It offers real-time glucose monitoring via a subcutaneous sensor, eliminating the need for frequent fingerstick blood tests. The system provides continuous glucose trend data and alerts for high or low glucose levels, helping users maintain better glycemic control and independence in managing their condition.
How is the Dexcom G6 system supplied, and what is the lifespan of the sensor?
The Dexcom G6 system includes a reusable transmitter paired with single-use sensors. Each sensor is applied to the skin and can be worn continuously for up to ten days before replacement. This design ensures convenience and reduces waste compared to disposable transmitters.
Does the Dexcom G6 require sterilization, and how should it be prepared for use?
The Dexcom G6 does not require sterilization beyond standard skin preparation before sensor application. Users should clean the application site with alcohol wipes to ensure proper adhesion and minimize infection risk. The sensor itself is sterile and ready for immediate use upon removal from its packaging.
Is the Dexcom G6 system safe to use during an MRI scan?
The Dexcom G6 system is not designed to operate within an MRI environment, though it does not actively interfere with MRI scans. However, the transmitter and sensor must be removed prior to MRI procedures due to their electronic components. This precaution ensures safety for both the user and the MRI facility.
What regulatory approval does the Dexcom G6 hold, and how is it classified?
The Dexcom G6 Continuous Glucose Monitoring System holds FDA 510(k) clearance (K182041) and is classified as a Class II medical device under 21 CFR 862.1355. It was determined to be substantially equivalent to a predicate device through the traditional review process by the FDA’s Clinical Chemistry Advisory Committee. This classification reflects its role in integrated continuous glucose monitoring for non-intensive diabetes management.
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 Continuous Glucose Monitoring System (CGM) | Dexcom, Dexcom G6 CGM System for Personal Use, Personal or Pro, Dexcom G6 CGM Systems enhances your care.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182041 | Class II | Active |
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Manufacturer
- Manufacturer
- Dexcom, Inc.
Sources (1)
- FDA 510(k) K182041 24 fields · synced Oct 1, 2026