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Agilia Infusion System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121613

by Fresenius Kabi AG

Identifiers

510(k) Number
K121613 FDA 510(k)
FDA Product Code
FRN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5725 FDA 510(k)
Regulation Number
880.5725 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Agilia Infusion System is a pump device designed for infusion therapy. It harmonizes a range of infusion pump types with a common interface that allows clinicians to safely shift between pump technologies. The system is supported by a unified software suite that works across all pump types in the Agilia range.

The Agilia Infusion System is manufactured by Fresenius Kabi AG and is intended for use in general hospital settings. It is a Class II medical device with FDA 510(k) clearance under product code FRN. The system includes various models and sizes, with specific model numbers and reference codes as registered with the appropriate authorities.

Frequently asked questions

What is the Agilia Infusion System designed for?

The Agilia Infusion System is designed for infusion therapy in general hospital settings. It harmonizes a range of infusion pump types with a common interface that allows clinicians to safely shift between pump technologies.

How is the Agilia Infusion System supplied?

The Agilia Infusion System is manufactured by Fresenius Kabi AG and includes various models and sizes with specific model numbers and reference codes as registered with the appropriate authorities. It is a Class II medical device.

What software supports the Agilia Infusion System?

The Agilia Infusion System is supported by a unified software suite that works across all pump types in the Agilia range, providing consistency and ease of use for healthcare providers.

What is the regulatory status of the Agilia Infusion System?

The Agilia Infusion System has FDA 510(k) clearance under product code FRN. It is classified as a Class II medical device and was determined to be substantially equivalent to predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Infusion Technology - Fresenius Kabi Global, Agilia SP - Fresenius Kabi Global, Agilia® SP MC | Fresenius Kabi, FRESENIUS KABI AGILIA SP TECHNICAL MANUAL Pdf Download

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fresenius Kabi AG

Sources (1)

  • FDA 510(k) K121613 24 fields · synced Sep 21, 2026