Mix2Vial Transfer Device
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231071 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 Mix2Vial Transfer Device is a medical device for transferring liquids between vials, designed to facilitate aseptic handling in pharmaceutical and clinical settings. It is classified as a liquid transfer device and is intended to minimize contamination risk during the preparation or manipulation of sterile solutions.
This device is supplied as a single-use, non-sterile component, requiring sterile preparation prior to use. It is compatible with standard vial sizes and is intended for use in controlled environments such as hospital pharmacies or sterile compounding areas. Authorized under FDA 510(k) clearance (K231071) and MDR compliance, it adheres to regulatory standards for liquid transfer systems in healthcare.
Frequently asked questions
What is the Mix2Vial® Transfer Device used for in a clinical or pharmaceutical setting?
The Mix2Vial® Transfer Device is specifically designed to transfer liquids between vials in a way that reduces contamination risk. It’s intended for aseptic handling during the preparation or manipulation of sterile solutions, making it useful in controlled environments like hospital pharmacies or sterile compounding areas where precision and sterility are critical.
Is the Mix2Vial® Transfer Device sterile when received, or does it require additional preparation?
The device is supplied as a non-sterile single-use component. It must be prepared under sterile conditions before use to ensure contamination-free liquid transfers, aligning with best practices for sterile compounding in healthcare settings.
Can this device be reused, or is it meant for one-time use only?
The Mix2Vial® Transfer Device is explicitly designed for single-use only. This design choice minimizes contamination risks and ensures compliance with aseptic handling protocols in pharmaceutical and clinical workflows.
What types of vial sizes is the Mix2Vial® Transfer Device compatible with?
The device is described as compatible with standard vial sizes, though exact dimensions or ranges aren’t specified. Its design focuses on facilitating transfers between typical vial types used in sterile compounding, ensuring versatility for common pharmaceutical applications.
How was the regulatory pathway for the Mix2Vial® Transfer Device determined, and what does that mean for its use?
The device was cleared via the FDA 510(k) pathway under the classification of a liquid transfer device, with a decision of *Substantially Equivalent* to a predicate product. This means it meets FDA standards for safety and effectiveness as a liquid transfer tool in controlled environments like hospital pharmacies, though its specific clinical indications are not detailed beyond minimizing contamination risk.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231071 | Class II | Active |
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Manufacturer
- Manufacturer
- West Pharma. Services IL, Ltd.
Sources (2)
- FDA 510(k) K231071 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026