iLet ACE Pump— 510(k) K253976
Substantially EquivalentBeta Bionics, Inc.
FDA 510(k) clearance K253976 for iLet ACE Pump, Substantially Equivalent on 2026-04-30. Applicant: Beta Bionics, Inc.. Device class: 2.
Summary
Beta Bionics' iLet ACE Pump is filed under product code QFG (Alternate Controller Enabled Insulin Infusion Pump).
Class II, 21 CFR 880.5730. It came in as a Traditional 510(k), and Clinical Chemistry is both the classification panel and the review panel.
Beta Bionics filed from Concord, Massachusetts. Review took 139 calendar days (December 12, 2025 to April 30, 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
- Concord, MA, 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.