510(k) K251139

KabiHelp® Uno; KabiHelp® Advance plus by Fresenius Kabi AG — Product Code KPE

K251139 is an FDA 510(k) premarket notification submitted by Fresenius Kabi AG for the device "KabiHelp® Uno; KabiHelp® Advance plus". The FDA issued a decision of Substantially Equivalent on January 9, 2026. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Fresenius Kabi AG has at least 10 other 510(k) clearances on record.