Mint ACE Pump— 510(k) K260001
Substantially EquivalentBeta Bionics, Inc.
FDA 510(k) clearance K260001 for Mint ACE Pump, Substantially Equivalent on 2026-09-11. Applicant: Beta Bionics, Inc.. Device class: 2.
Summary
The Mint ACE Pump is an insulin pump from Beta Bionics. Its product code, QFG, covers alternate controller enabled (ACE) insulin pumps. The code's definition says these are designed to communicate reliably and securely with external devices, such as automated insulin dosing systems, and can be used alone or with digitally connected devices.
Class II, 21 CFR 880.5730. The record lists Clinical Chemistry as the reviewing panel. Traditional 510(k).
Beta Bionics filed from Irvine, California. Review took 252 days (January 2 to September 11, 2026).
Clearance details
- Applicant
- Beta Bionics, Inc.
- Product code
- Product code QFG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5730
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code QFG
view allMore clearances from Beta Bionics, Inc.
view allAdverse 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, 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.