iLet® ACE Pump— 510(k) K231485

Substantially Equivalent

Beta Bionics, Inc.

FDA 510(k) clearance K231485 for iLet® ACE Pump, Substantially Equivalent on 2023-06-21. Applicant: Beta Bionics, Inc..

Clearance details

Applicant: Beta Bionics, Inc.
Product code: Code QFG
Advisory panel: Clinical Chemistry
Date received: 2023-05-23
Decision date: 2023-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Concord, MA, US

Download summary PDF View on FDA.gov ↗

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.