Vygon Latex Free Bionector
FDA 510(k)Class II (US FDA 510(k))
by Vygon Corp.
Identifiers
- 510(k) Number
- K052881 FDA 510(k)
- FDA Product Code
- FOZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5200 FDA 510(k)
- Regulation Number
- 880.5200 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vygon Latex-Free Bionector is a needle-free connector classified as a closed-system catheter accessory (Product Code: FOZ). It provides a sterile, contamination-free interface for intravenous (IV) circuits, enabling fluid infusion, medication administration, blood sampling, and tubing changes without exposing the system to the atmosphere. Its design eliminates the risk of latex exposure while maintaining a secure, leak-proof seal between Luer-lock components. The device is intended for use with standard Luer fittings, ensuring compatibility with existing IV systems in clinical settings.
The Vygon Latex-Free Bionector is supplied as a single-use, sterile device and is regulated under FDA 510(k) clearance (K052881) as substantially equivalent to predicate technology. It is designed for use in general hospital settings, including critical care, neonatal, pediatric, and adult care environments. The device features a male/female Luer connection with a self-sealing membrane that opens only when a Luer fitting is disconnected, preventing fluid leakage and maintaining circuit integrity. Storage instructions and MRI safety are not specified in the regulatory data.
Frequently asked questions
What is the Vygon Latex-Free Bionector used for?
The Vygon Latex-Free Bionector is designed as a needle-free connector for closed-system catheter accessories (Product Code: FOZ). It creates a sterile, contamination-free interface between IV circuits, enabling safe fluid infusion, medication administration, blood sampling, and tubing changes. Its primary purpose is to eliminate the risk of latex exposure while maintaining a secure, leak-proof seal between Luer-lock components, ensuring compatibility with existing IV systems in clinical environments like critical care, neonatal, pediatric, and adult care.
Is the Vygon Latex-Free Bionector latex-free and single-use?
Yes, the Vygon Latex-Free Bionector is explicitly designed to be latex-free, removing the risk of latex exposure for patients or staff. It is also supplied as a single-use, sterile device, ensuring each use is safe and contamination-free without requiring reprocessing.
How does the Vygon Latex-Free Bionector maintain circuit integrity?
The device features a male/female Luer connection with a self-sealing membrane that remains intact until a Luer fitting is disconnected. This design prevents fluid leakage and maintains the integrity of the IV circuit, even during tubing changes or disconnections, while still allowing secure reconnection.
What types of Luer fittings is the Vygon Latex-Free Bionector compatible with?
The Vygon Latex-Free Bionector is engineered to work with standard Luer-lock fittings, ensuring seamless integration with existing IV systems in hospitals. This compatibility allows clinicians to use it without modifying their current setup, making it versatile for general hospital use.
What regulatory clearance does the Vygon Latex-Free Bionector hold?
The device holds FDA 510(k) clearance (K052881) and is classified as substantially equivalent to predicate technology. This clearance confirms its safety and effectiveness for use as a closed-system catheter accessory in clinical settings, including critical care, neonatal, pediatric, and adult care.
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: Bionector - Needle-free connectors | Vygon, Needle-free connectors - Vascular products | Vygon, VYGON LATEX FREE BIONECTOR (K052881) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K052881 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vygon Corp.
Sources (1)
- FDA 510(k) K052881 24 fields · synced Oct 1, 2026