K251139 is an FDA 510(k) clearance for the KabiHelp® Uno. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Fresenius Kabi AG (Bad Homburg, DE). The FDA issued a Cleared decision on January 9, 2026, 270 days after receiving the submission on April 14, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K251139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2025 |
| Decision Date | January 09, 2026 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KPE - Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |