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, the company that makes the iLet bionic pancreas. Its product code, QFG, covers alternate controller enabled (ACE) pumps. These are pumps designed to work as interchangeable parts alongside separately cleared dosing algorithms and CGMs.
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). ACE pumps carry special controls on dose accuracy, interoperability, and cybersecurity, so eight months for what looks like a new pump name isn't surprising.
Clearance details
- Applicant
- Beta Bionics, Inc.
- Product code
- 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.