DeviceClearance

Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System— 510(k) K253737

Substantially Equivalent

Dexcom, Inc.

FDA 510(k) clearance K253737 for Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System, Substantially Equivalent on 2026-02-03. Applicant: Dexcom, Inc.. Device class: 2.

Summary

Dexcom lists two names, the Dexcom G7 Continuous Glucose Monitoring (CGM) System and the Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System, under product code QBJ (Integrated Continuous Glucose Monitoring System, Factory Calibrated). The record says nothing about how the two differ beyond their names.

Class II, 21 CFR 862.1355. Clinical Chemistry is both the classification panel and the review panel. It came in as a Traditional 510(k).

Dexcom filed from San Diego, California. Review took 71 calendar days (November 24, 2025 to February 3, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant
Dexcom, Inc.
Product code
Product code QBJ
Device class
Class 2
Regulation
21 CFR 862.1355
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code QBJ

product code QBJ
Death
180
Injury
31,825
Malfunction
1,792,244
Other
36
Total
1,824,285

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.