Dexcom G6 Continuous Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
by Dexcom, Inc.
Identifiers
- 510(k) Number
- K201328 FDA 510(k)
- FDA Product Code
- QBJ 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 is an integrated continuous glucose monitoring system designed to track glucose levels in patients with diabetes. The system transmits glucose readings to a compatible smart device or receiver every five minutes to assist in diabetes management.
This device is indicated for use in persons aged 2 years and older and features a factory-calibrated sensor. It has received FDA 510(k) clearance as an integrated continuous glucose monitoring system.
Frequently asked questions
Who is the Dexcom G6 indicated for?
The Dexcom G6 is indicated for use in persons aged 2 years and older who require assistance in tracking their glucose levels for diabetes management.
How often does the system provide glucose readings?
The system is designed to transmit glucose readings to a compatible smart device or receiver every five minutes to provide consistent data for diabetes management.
Does the sensor require manual calibration?
No, the Dexcom G6 features a factory-calibrated sensor, which simplifies the setup process for the user by removing the need for manual calibration.
What is the regulatory status of this device?
The Dexcom G6 has received FDA 510(k) clearance as an integrated continuous glucose monitoring system, filed under K201328.
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: What is the Dexcom G6 Continuous Glucose Monitoring (CGM) System?, Dexcom G6 Integrated Continuous Glucose Monitoring (CGM) System, Dexcom G6 CGM System for Personal Use, Dexcom G6 (continuous glucose monitor): Uses, FAQs ... - GoodRx
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201328 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dexcom, Inc.
Sources (1)
- FDA 510(k) K201328 24 fields · synced Sep 27, 2026