510(k) K242775 ยท NDC Calculator, Drug Dose
InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
| Applicant | Medtronic Minimed, Northridge CA, US |
| Decision | Substantially Equivalent, Nov 12, 2024 |
| Received | Sep 13, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242775
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | Medtronic MiniMed, Inc. InPen App, Model/CFN Number: MMT-8061 (Android Users) Open, Classified |
NDC | None listed |
| Sep 2, 2025 | Medtronic MiniMed, Inc. InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) Open, Classified |
NDC | None listed |
| Apr 21, 2025 | Medtronic MiniMed, Inc. InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA Open, Classified |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.