Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi AG. It received FDA 510(k) clearance on 2026-01-09 under 510(k) 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. The listed applicant is Fresenius Kabi AG. The 510(k) number is K251139.

When did KabiHelp® Uno; KabiHelp® Advance plus receive FDA 510(k) clearance?

KabiHelp® Uno; KabiHelp® Advance plus received FDA 510(k) clearance on 2026-01-09, under 510(k) number K251139.

Who is the listed applicant for KabiHelp® Uno; KabiHelp® Advance plus?

The FDA 510(k) record lists Fresenius Kabi AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KabiHelp® Uno; KabiHelp® Advance plus?

The FDA product code for KabiHelp® Uno; KabiHelp® Advance plus is KPE.

Other records listing Fresenius Kabi AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221121Volumat Polyethylene I.V. Administration SetK220301Volumat LineK212445freeflex+ Transfer AdapterK210075Vigilant Software Suite – Vigilant Master MedK210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB CableK210073Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo

View all 13 devices →

Related Devices (Code: KPE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , Ltd.K223674eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic Medical Pte. , Ltd.

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.

↑