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SmartSiteTM Vented Vial Access Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243486

by Yukon Medical, LLC

Identifiers

510(k) Number
K243486 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 SmartSite Vented Vial Access Device is a vented vial access system designed for safe and sterile access to standard 20 mm rubber-stopper medication vials. It facilitates reconstitution or dispensing of medications in controlled environments, ensuring minimal exposure to air and contamination during use.

Intended for healthcare professionals, patients, and caregivers, this device is used in clinical and home settings. Supplied as a single-use item, it adheres to FDA 510(k) clearance (K243486) and is compatible exclusively with 20 mm vials. Sterility and proper handling are critical for maintaining medication integrity, and it must be stored according to manufacturer guidelines to preserve functionality.

Frequently asked questions

What clinical settings is the SmartSite Vented Vial Access Device designed for, and who can use it?

The SmartSite Vented Vial Access Device is designed for use in both clinical environments like hospitals and home settings, where healthcare professionals, patients, and caregivers may need to safely access medication vials. Its vented system helps minimize air exposure and contamination during reconstitution or dispensing, making it suitable for controlled environments where sterility is critical.

Is the SmartSite Vented Vial Access Device reusable, or is it meant for single-use only?

The SmartSite Vented Vial Access Device is explicitly supplied as a single-use item. This design ensures sterility and reduces the risk of contamination during medication access, which is essential for maintaining medication integrity and patient safety.

What type of medication vials is this device compatible with, and why?

The SmartSite Vented Vial Access Device is designed exclusively for use with 20 mm rubber-stopper medication vials. Its compatibility is limited to this specific size to ensure a secure, leak-proof seal and proper functionality during vial access, preventing air leakage or contamination.

How should the SmartSite Vented Vial Access Device be stored to maintain its functionality?

The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is single-use, proper storage conditions—such as avoiding moisture, extreme temperatures, or direct light—are likely required to prevent degradation before use.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for users?

The SmartSite Vented Vial Access Device received FDA clearance through a 510(k) submission (K243486), classified as *Substantially Equivalent* under the Traditional review pathway. This means the FDA determined it is as safe and effective as a legally marketed predicate device, ensuring it meets regulatory standards for safety and performance in clinical use.

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: K243486 FDA 510(k) - SmartSiteTM Vented Vial Access Device, SmartSiteTM Vented Vial Access Device (K243486) - Innolitics, PDF K243486 - SmartSiteTM Vented Vial Access Device, K243486 FDA 510(k) - SmartSiteTM Vented Vial Access Device

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Yukon Medical, LLC

Sources (1)

  • FDA 510(k) K243486 24 fields · synced Sep 19, 2026