510(k) K261461 ยท QJI Interoperable Automated Glycemic Controller
Omnipod 6 algorithm
| Applicant | Insulet Corporation, Acton MA, US |
| Decision | Substantially Equivalent, Jun 29, 2026 |
| Received | May 4, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261461
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.