Identifiers
- 510(k) Number
- K120799 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 Arisure Neutral Valve is a closed-system transfer device (CSTD) designed for the safe preparation and administration of hazardous injectable medications. It facilitates needle-free transfer between compatible containers, reducing the risk of exposure to hazardous drugs while maintaining sterility and integrity of the medication.
This single-use valve is intended for use in hospital settings, where it connects to luer-lock systems for seamless integration into existing workflows. Supplied sterile and packaged individually, it complies with FDA 510(k) clearance under K120799 and meets the requirements of the Medical Device Directive (MDD). The device is classified under product code FPA and is intended for one-time use only.
Frequently asked questions
What types of hazardous medications can the Arisure Neutral Valve be used with, and how does it ensure safety during transfer?
The Arisure Neutral Valve is designed for the safe transfer of hazardous injectable medications between compatible containers in a closed-system setup. It eliminates the need for needles or syringes, reducing the risk of exposure to hazardous drugs during preparation and administration. The device maintains sterility and medication integrity by preventing contamination through its sealed design, making it suitable for use with any hazardous injectable medication that can be transferred via luer-lock systems.
Is the Arisure Neutral Valve reusable, or is it meant for single-use only? How does this affect its use in a hospital setting?
The Arisure Neutral Valve is explicitly designed for one-time use only, as stated in its specifications. This single-use nature helps minimize the risk of contamination or cross-exposure between patients, ensuring compliance with infection control protocols in hospital settings. Hospitals must adhere to this restriction to maintain safety and sterility standards during hazardous medication handling.
How is the Arisure Neutral Valve packaged and stored, and what precautions should be taken before use?
The device is supplied sterile and individually packaged to preserve its integrity. Before use, healthcare providers should ensure the packaging remains unopened and intact. Storage should follow standard sterile supply protocols—keep the valve in its sealed packaging until immediately before use, and avoid exposure to moisture, extreme temperatures, or direct sunlight. This maintains sterility and functionality for safe hazardous drug transfer.
What luer-lock compatibility does the Arisure Neutral Valve have, and how does it integrate into existing hospital workflows?
The Arisure Neutral Valve is designed to connect seamlessly to luer-lock systems, allowing it to integrate directly into existing hospital workflows without requiring additional equipment. This compatibility ensures compatibility with standard infusion sets, syringes, and other luer-lock devices commonly used in medication preparation and administration, reducing training needs and operational disruption.
What regulatory pathways does the Arisure Neutral Valve follow, and how does this affect its use in clinical settings?
The device follows FDA 510(k) clearance (K120799) under the Traditional pathway, with a decision of *Substantially Equivalent* to a predicate device, and also complies with the Medical Device Directive (MDD). Clinically, this means it has undergone regulatory review for safety and effectiveness in reducing exposure risks during hazardous drug handling. Hospitals can rely on this clearance to ensure the device meets established standards for closed-system transfer devices in their protocols.
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: Arisure® Closed System Transfer Device | Yukon Medical, Medical Devices for Medication Preparation - Yukon, Yukon Medical | Progressive Medical, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K120799 | Class II | Active |
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Manufacturer
- Manufacturer
- Yukon Medical, LLC
Sources (2)
- FDA 510(k) K120799 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026