510(k) K231485 · QFG Alternate Controller Enabled Insulin Infusion Pump
iLet® ACE Pump
| Applicant | Beta Bionics, Inc., Concord MA, US |
| Decision | Substantially Equivalent, Jun 21, 2023 |
| Received | May 23, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231485
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2026 | Beta Bionics, Inc. iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software Open, Classified |
QFG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.