DeviceClearance

Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System— 510(k) K261402

Substantially Equivalent

Dexcom, Inc.

FDA 510(k) clearance K261402 for Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System, Substantially Equivalent on 2026-06-08. Applicant: Dexcom, Inc.. Device class: 2.

Summary

Dexcom's clearance covers the Dexcom G7 Continuous Glucose Monitoring System and the Dexcom G7 15 Day Continuous Glucose Monitoring System. The record lists one product code, QBJ, factory-calibrated integrated continuous glucose monitoring systems, and doesn't describe either system beyond its name.

Class II, 21 CFR 862.1355. Clinical Chemistry is both the classification panel and the review panel, and the submission was a Traditional 510(k).

Dexcom filed from San Diego, California. Review took 40 calendar days (April 29 to June 8, 2026).

Clearance details

Device name as filed
Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System
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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More clearances from Dexcom, Inc.

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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.