K252770

Substantially Equivalent

iLet ACE Pump

Applicant: Beta Bionics, Inc.
Product code: QFG
Advisory panel: Clinical Chemistry
Date received: 2025-09-02
Decision date: 2025-09-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Concord, MA, US

Adverse events under product code QFG

product code QFG

Death: 228
Injury: 118,915
Malfunction: 1,001,752
Other: 7
Total: 1,120,902

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.