510(k) K253976 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
iLet ACE Pump
| Applicant | Beta Bionics, Inc., Concord MA, US |
| Decision | Substantially Equivalent, Apr 30, 2026 |
| Received | Dec 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253976
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.