510(k) K253585 ยท QJI Interoperable Automated Glycemic Controller
SmartGuard technology; Predictive Low Glucose technology
| Applicant | Medtronic Minimed, Inc., Northridge CA, US |
| Decision | Substantially Equivalent, Jan 14, 2026 |
| Received | Nov 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253585
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.