Dexcom G6 Pro Continuous Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
by Dexcom, Inc.
Identifiers
- 510(k) Number
- K191833 FDA 510(k)
- FDA Product Code
- QII 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 Pro Continuous Glucose Monitoring System is an integrated device classified as a Continuous Glucose Monitoring System for Professional Directed Retrospective or Real-Time Use. It provides continuous, non-invasive glucose readings to support clinical management of diabetes in patients aged two years and older, eliminating the need for traditional fingerstick blood glucose testing.
This system consists of a sensor, transmitter, and optional Dexcom G6 app for real-time glucose monitoring. It is intended for professional use, delivering automated glucose readings every five minutes to a compatible smart device or receiver. The device is single-use, with a 10-day sensor lifespan, and requires no scanning or calibration. It is regulated under FDA 510(k) clearance (K191833) and falls under Class II medical devices, adhering to regulatory standards for clinical chemistry applications.
Frequently asked questions
What is the Dexcom G6 Pro Continuous Glucose Monitoring System used for?
The Dexcom G6 Pro Continuous Glucose Monitoring System is designed for professional-directed retrospective or real-time glucose monitoring in patients aged two years and older with diabetes. It replaces traditional fingerstick blood glucose tests by delivering continuous, non-invasive glucose readings every five minutes, helping clinicians manage diabetes more effectively.
How is the Dexcom G6 Pro system supplied and what does it include?
The system consists of three main components: a sensor, a transmitter, and an optional Dexcom G6 app for real-time monitoring. The sensor is single-use with a lifespan of up to 10 days, and it transmits glucose readings automatically to a compatible smart device or receiver. No scanning or calibration is required, simplifying the monitoring process.
Is the Dexcom G6 Pro system sterile and intended for single-use?
Yes, the Dexcom G6 Pro system is designed for single-use only. The sensor is intended to be used for up to 10 days per application, after which it should be replaced. Sterility is maintained through the manufacturing process, ensuring safe and reliable use for each patient.
What regulatory approval does the Dexcom G6 Pro system hold?
The Dexcom G6 Pro Continuous Glucose Monitoring System holds FDA 510(k) clearance under the reference number K191833. This clearance confirms that the device meets regulatory standards for Class II medical devices, specifically for clinical chemistry applications, and is substantially equivalent to a predicate device.
How does the Dexcom G6 Pro system differ from other CGM systems?
The Dexcom G6 Pro system is specifically designed for professional-directed use, providing automated glucose readings every five minutes without requiring calibration or scanning. Its 10-day sensor lifespan and integration with a transmitter and optional app make it ideal for continuous monitoring in clinical settings, offering a seamless experience for both patients and healthcare providers.
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: Professional Continuous Glucose Monitoring | Dexcom G6 Pro | Dexcom ..., What is the Dexcom G6 Pro Continuous Glucose Monitoring (CGM) System?, Dexcom G6 CGM System | No Fingersticks, No Scanning | Dexcom, DEXCOM G6 PRO USER MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191833 | Class II | Active |
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Manufacturer
- Manufacturer
- Dexcom, Inc.
Sources (1)
- FDA 510(k) K191833 24 fields · synced Oct 1, 2026