Vented Vial Adapter 20mm
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213513 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 Vented Vial Adapter 20mm is a medical device designed as a connector for vials, facilitating the transfer of liquids while allowing gas exchange to prevent pressure buildup. It falls under the category of vial adapters, ensuring compatibility with standard vial systems in clinical settings.
This device is intended for single-use in hospital environments, as indicated by its FDA 510(k) clearance under the General Hospital advisory committee. Supplied sterile and packaged individually, it adheres to the Medical Device Directive (MDD) and Medical Device Regulation (MDR) standards. The 20mm size ensures precise fitting for vial systems, and no MRI safety concerns are noted in the specifications.
Frequently asked questions
What is the primary purpose of the Vented Vial Adapter 20mm in a clinical setting?
The Vented Vial Adapter 20mm is designed to connect to vials and enable the safe transfer of liquids while allowing gas to escape. This prevents pressure buildup inside the vial during use, which is critical for maintaining sterility and preventing leaks or damage to the vial system.
Is the Vented Vial Adapter 20mm intended for reuse in a hospital environment?
No, the device is explicitly labeled for single-use only in hospital settings. This is supported by its FDA 510(k) clearance under the General Hospital advisory committee, which specifies its intended use in clinical environments where single-use medical devices are standard practice.
How is the Vented Vial Adapter 20mm packaged and what does this imply for handling?
The adapter is supplied sterile and individually packaged, ensuring it remains uncontaminated until use. This packaging design aligns with medical device standards (MDD/MDR) and minimizes the risk of cross-contamination, making it ready for immediate use without additional sterilization.
What size does the Vented Vial Adapter 20mm refer to, and why is this important?
The 20mm designation indicates the adapter’s diameter, ensuring compatibility with standard vial systems that use this size. This precise fit is essential for secure attachment, preventing leaks or improper connections during liquid transfer or gas exchange.
Are there any special considerations for storage or handling of the Vented Vial Adapter 20mm?
While specific storage instructions aren’t detailed in the data, the adapter’s sterile, single-use packaging implies it should be stored in a clean, dry environment protected from physical damage or contamination. Since it’s not reusable, unopened units should be kept until use to maintain sterility.
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
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213513 | Class II | Active |
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Manufacturer
- Manufacturer
- West Pharma. Services IL, Ltd.
Sources (2)
- FDA 510(k) K213513 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026