Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System— 510(k) K221259

Substantially Equivalent

Dexcom, Inc.

FDA 510(k) clearance K221259 for Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System, Substantially Equivalent on 2022-07-29. Applicant: Dexcom, Inc..

Clearance details

Applicant: Dexcom, Inc.
Product code: Code QBJ
Advisory panel: Clinical Chemistry
Date received: 2022-05-02
Decision date: 2022-07-29
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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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, 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.