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Vialok Single Vial Access Device Vented

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K122265

by Yukon Medical, LLC

Identifiers

510(k) Number
K122265 FDA 510(k)
FDA Product Code
LHI 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 Vialok Single Vial Access Device Vented is a vented single-use vial access device designed for sterile connection to glass or plastic vials containing injectable medications. It provides a secure, needle-free interface to withdraw or administer fluids while preventing contamination and maintaining sterility during use.

This device is intended for single-use in hospital or clinical settings and is supplied sterile. It is classified under product code LHI and has been authorized through FDA 510K clearance (K122265) and MDD compliance. The vented design allows for pressure equalization during fluid transfer, ensuring accurate dosing and minimizing air entrainment.

Frequently asked questions

What types of vials can the Vialok Single Vial Access Device Vented be used with, and why is the vented design important during fluid transfer?

The Vialok Single Vial Access Device Vented is designed for sterile connection to both glass and plastic vials containing injectable medications. The vented design is crucial because it allows for pressure equalization during fluid withdrawal or administration, which prevents vacuum formation in the vial and minimizes air entrainment. This ensures accurate dosing and reduces the risk of medication waste or contamination.

Is the Vialok Single Vial Access Device Vented intended for reuse, and if not, how should it be handled after use?

No, the Vialok Single Vial Access Device Vented is explicitly designed for single-use only in hospital or clinical settings. After use, it should be discarded according to standard medical waste protocols to prevent contamination and maintain infection control standards.

How is the Vialok Single Vial Access Device Vented supplied, and what does 'sterile' mean in this context?

The device is supplied sterile and ready for immediate use, packaged in a way that preserves its sterility until opening. 'Sterile' means it has undergone validation processes to eliminate all viable microorganisms, ensuring a contamination-free interface for medication access.

What clinical settings or environments is this device authorized for, and how does its regulatory pathway support its use?

The Vialok Single Vial Access Device Vented is authorized for use in hospital or clinical settings, as indicated by its FDA 510(k) clearance (K122265) under product code LHI (Hospital Products) and compliance with the Medical Device Directive (MDD). Its regulatory pathway confirms it meets safety and performance standards for sterile, needle-free vial access in controlled environments.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Yukon Medical, LLC

Sources (2)

  • FDA 510(k) K122265 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026