KabiHelp® Uno; KabiHelp® Advance plus
K-Number: K251139 · 2026-01-09
ApplicantFresenius Kabi AG
Decision Date2026-01-09
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
KabiHelp® Uno; KabiHelp® Advance plus is a medical device manufactured by Fresenius Kabi AG. It received FDA 510(k) clearance on 2026-01-09 under approval number K251139. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the KabiHelp® Uno; KabiHelp® Advance plus?
KabiHelp® Uno; KabiHelp® Advance plus is a medical device that received FDA 510(k) clearance on 2026-01-09. It is manufactured by Fresenius Kabi AG. The 510(k) number is K251139.
When was KabiHelp® Uno; KabiHelp® Advance plus approved by the FDA?
KabiHelp® Uno; KabiHelp® Advance plus received FDA 510(k) clearance on 2026-01-09, under approval number K251139.
What company makes KabiHelp® Uno; KabiHelp® Advance plus?
KabiHelp® Uno; KabiHelp® Advance plus is manufactured by Fresenius Kabi AG.
What is the FDA product code for KabiHelp® Uno; KabiHelp® Advance plus?
The FDA product code for KabiHelp® Uno; KabiHelp® Advance plus is KPE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.