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Volumat Polyethylene I.V. Administration Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221121

by Fresenius Kabi

Identifiers

510(k) Number
K221121 FDA 510(k)
FDA Product Code
FPA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5440 FDA 510(k)
Regulation Number
880.5440 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Volumat Polyethylene I.V. Administration Set is a polyethylene intravenous administration set designed for fluid infusion. It is classified under the General Hospital category and serves as a conduit for delivering intravenous medications, fluids, or nutrients to patients in clinical settings. The set is engineered to connect to volumetric infusion pumps, ensuring precise and controlled delivery of infusions. Its construction supports compatibility with infusion systems while maintaining sterility and safety standards for patient use.

This administration set is supplied as a single-use, sterile device and is intended for use with Agilia or Exelia volumetric infusion pumps. It is manufactured from polyethylene, ensuring durability and reliability during infusion procedures. The set is regulated under FDA 510(k) clearance (K221121) and is designed for hospital environments, adhering to strict medical device standards. Storage instructions and size specifications are consistent with standard intravenous administration sets, requiring no additional handling beyond sterile packaging.

Frequently asked questions

What is the Volumat Polyethylene I.V. Administration Set designed for?

The Volumat Polyethylene I.V. Administration Set is specifically engineered to serve as a conduit for delivering intravenous medications, fluids, or nutrients to patients in clinical environments. Its primary function is to connect to volumetric infusion pumps (such as Agilia or Exelia models) to enable precise and controlled infusion of fluids, ensuring accurate dosing and reliable delivery.

Is this administration set single-use or reusable?

This administration set is designed for single-use only. It is supplied in sterile packaging to maintain patient safety and prevent contamination during infusion procedures. After use, the set should be discarded to comply with medical device sterility standards.

Which volumetric infusion pumps is this set compatible with?

The Volumat Polyethylene I.V. Administration Set is intended for use exclusively with Fresenius Kabi’s Agilia or Exelia volumetric infusion pumps. Compatibility is ensured by the set’s engineering to integrate seamlessly with these systems, enabling accurate fluid delivery while adhering to the pump’s operational parameters.

How should the Volumat Polyethylene I.V. Administration Set be stored?

Storage follows standard protocols for sterile intravenous administration sets. The set should remain in its original, unopened packaging until immediately before use to preserve sterility. Avoid exposure to extreme temperatures, moisture, or direct sunlight, and ensure the packaging remains intact to prevent contamination.

What material is the administration set made from, and why does it matter?

The set is manufactured from polyethylene, a durable and chemically inert material that ensures compatibility with a wide range of intravenous fluids, medications, and nutrients. Polyethylene’s properties reduce the risk of leaching or adverse reactions, while its strength supports reliable performance during infusion procedures without compromising patient safety.

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: Agilia Volumat Dedicated Admin Sets | KabiAccess - Fresenius Kabi, PDF Volumat Line of Administration Sets - Fresenius Kabi, PDF Volumat Lines - Fresenius Kabi Global, Volumat Polyethylene I.V. Administration Set 510 (k)… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fresenius Kabi

Sources (1)

  • FDA 510(k) K221121 24 fields · synced Oct 1, 2026