510(k) K252770 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
iLet ACE Pump
| Applicant | Beta Bionics, Inc., Concord MA, US |
| Decision | Substantially Equivalent, Sep 29, 2025 |
| Received | Sep 2, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252770
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2026 | Beta Bionics, Inc. iLet Bionic Pancreas, REF: BB1001 Open, Classified |
QFG | None listed |
| Apr 29, 2026 | Beta Bionics, Inc. iLet Bionic Pancreas, REF: BB1001 Open, Classified |
QFG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.