510(k) K201337 ยท NDC Calculator, Drug Dose
InPen System
| Applicant | Companion Medical, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 18, 2020 |
| Received | May 20, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201337
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Dec 20, 2022 | Companion Medical, Inc. InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA. Open, Classified |
NDC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.