510(k) K251139 · KPE Container, I.V.
KabiHelp® Uno; KabiHelp® Advance plus
| Applicant | Fresenius Kabi AG, Bad Homburg, DE |
| Decision | Substantially Equivalent, Jan 9, 2026 |
| Received | Apr 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251139
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.