K251139
- 510(k) number
- K251139
- Device name
- KabiHelp® Uno; KabiHelp® Advance plus
- Applicant
- Fresenius Kabi AG DE
- Product code
- KPE — Container, I.V.
- Decision date
- 2026-01-09
- Date received
- 2025-04-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251139.pdf
Official FDA record: K251139
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.