510(k) K260001 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Mint ACE Pump
| Applicant | Beta Bionics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 11, 2026 |
| Received | Jan 2, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260001
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.