Dexcom G6 Continuous Glucose Monitoring (CGM) System— 510(k) K201328

Substantially Equivalent

Dexcom, Inc.

FDA 510(k) clearance K201328 for Dexcom G6 Continuous Glucose Monitoring (CGM) System, Substantially Equivalent on 2021-07-15. Applicant: Dexcom, Inc..

Clearance details

Applicant: Dexcom, Inc.
Product code: Code QBJ
Advisory panel: Clinical Chemistry
Date received: 2020-05-19
Decision date: 2021-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.