Dexcom G7 Continuous Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
by Dexcom, Inc.
Identifiers
- 510(k) Number
- K234133 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 G7 Continuous Glucose Monitoring System is an integrated continuous glucose monitoring system that is factory calibrated. It is classified as a Class II medical device under regulation number 862.1355 and product code QBJ.
The device received FDA 510(k) clearance (K234133) on February 26, 2024, and is substantially equivalent to a predicate device. It is manufactured by Dexcom, Inc. in San Diego, California, and is intended for use in clinical chemistry settings as indicated by the advisory committee classification.
Frequently asked questions
What is the Dexcom G7 Continuous Glucose Monitoring System used for?
The Dexcom G7 is an integrated continuous glucose monitoring system designed for real-time glucose tracking in clinical chemistry settings, as indicated by its advisory committee classification, providing factory-calibrated glucose readings without user fingerstick calibration.
How is the Dexcom G7 supplied and is it sterile or single-use?
The Dexcom G7 is supplied as a disposable, single-use sensor applicator and transmitter unit that is sterile upon delivery; each sensor is intended for one-time use over a 10-day wear period and must be discarded after use to maintain performance and safety.
What regulatory pathway was used for the Dexcom G7 and what is its classification?
The Dexcom G7 received FDA 510(k) clearance under K234133 on February 26, 2024, and is classified as a Class II medical device under regulation 862.1355 with product code QBJ, based on substantial equivalence to a predicate device.
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 Continuous Glucose Monitoring - The most accurate CGM system ..., Dexcom G7 15 Day CGM Sensor for Managing Diabetes | Dexcom, Your Guide to the Dexcom G7 CGM - Healthline, Class 2 Device Recall Dexcom G7 Continuous Glucose Monitoring System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K234133 | Class II | Active |
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Manufacturer
- Manufacturer
- Dexcom, Inc.
Sources (1)
- FDA 510(k) K234133 24 fields · synced Sep 27, 2026