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Vial Adapter with Filter

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K233284

by Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

Identifiers

510(k) Number
K233284 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 Vial Adapter with Filter is a sterile, single-use medical device designed to connect and transfer fluids between vials while preventing contamination. It incorporates a built-in filter to ensure particulate-free transfer, making it suitable for pharmaceutical and laboratory applications requiring aseptic handling.

This device is supplied as a sterile, disposable component intended for use in hospital settings, as indicated by its advisory committee classification. It is intended for single-use only and must be discarded after use to maintain sterility. The device adheres to FDA 510(k) clearance and MDR requirements, ensuring compliance with regulatory standards for medical devices.

Frequently asked questions

What is the primary purpose of the Vial Adapter with Filter in a clinical setting?

The Vial Adapter with Filter is designed to connect and transfer fluids between vials while preventing contamination. Its built-in filter ensures particulate-free transfer, making it ideal for pharmaceutical and laboratory applications where aseptic handling is critical. This helps maintain the sterility of substances being transferred, reducing the risk of microbial or particulate contamination.

Is this device reusable, or is it meant for single-use only?

This device is explicitly intended for single-use only. It is supplied sterile and must be discarded after use to preserve sterility and prevent cross-contamination. Reusing it could compromise its performance and safety.

How is the Vial Adapter with Filter supplied, and where would it typically be used?

The device is supplied as a sterile, disposable component, packaged for single-use. It is classified under the advisory committee category for General Hospital applications, indicating its primary use in hospital settings where aseptic fluid transfer between vials is required.

What regulatory pathways does this device follow, and what does that mean for compliance?

The Vial Adapter with Filter follows both FDA 510(k) clearance and MDR (Medical Device Regulation) pathways, ensuring it meets stringent regulatory standards for safety and performance. This means it has undergone evaluation to confirm it is substantially equivalent to a predicate device and complies with global medical device regulations, providing assurance of its reliability 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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

Sources (2)

  • FDA 510(k) K233284 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026