Vial Adapter Ø20 mm
by Avenir Performance Europeenne Medical (Apem)
510(k) K190149
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190149 | Date15 Oct 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Vial Adapter Ø20 mm is a medical device classified as a Set, I.V. Fluid Transfer (product code LHI), designed to facilitate the secure connection between intravenous (I.V.) administration sets and vial stoppers. It ensures a sterile and leak-proof interface, enabling safe medication transfer from a vial to an I.V. line while minimizing contamination risks. Constructed for compatibility with standard vial sizes, it adheres to regulatory standards for fluid transfer systems in clinical settings.
This device is intended for single-use in healthcare environments, including hospitals and outpatient care, where sterile fluid administration is required. Supplied sterile and packaged individually, it must be handled with aseptic technique to maintain integrity. The adapter’s Ø20 mm diameter aligns with common vial stopper sizes, ensuring proper fit and functionality. Authorized under FDA 510(k) clearance (K190149), it complies with Class II special controls for I.V. fluid transfer systems, ensuring safety and performance in prescribed applications.
Other devices from Avenir Performance Europeenne Medical (Apem)
Questions
AI-generated answers, 1 Oct 2026
What is the Vial Adapter Ø20 mm designed for?
The Vial Adapter Ø20 mm is specifically engineered to create a secure, sterile connection between intravenous (I.V.) administration sets and vial stoppers. This design minimizes the risk of contamination and leaks during the transfer of medications from a vial into an I.V. line, ensuring safe and reliable fluid administration in clinical settings.
How is the Vial Adapter Ø20 mm supplied and should it be reused?
The Vial Adapter Ø20 mm is supplied sterile and packaged individually for single-use only. Reuse is not recommended due to the risk of compromising sterility and integrity, which could lead to contamination or device failure. Always adhere to aseptic technique when handling to maintain its intended performance.
What vial stopper sizes is this adapter compatible with?
The adapter is designed with a Ø20 mm diameter, making it compatible with standard vial stopper sizes commonly used in healthcare settings. This ensures a proper fit and reliable functionality during medication transfer, reducing the risk of leaks or improper connections.
How should the Vial Adapter Ø20 mm be stored?
The adapter should be stored in its original, unopened packaging to preserve sterility. Keep it in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants, as this could compromise its integrity before use.
Is this device regulated by the FDA, and what does that mean for its use?
Yes, the Vial Adapter Ø20 mm holds an FDA 510(k) clearance (K190149), meaning it has been determined to be substantially equivalent to a legally marketed device. This regulatory clearance ensures it meets Class II special controls for I.V. fluid transfer systems, confirming its safety and performance for the intended clinical applications.