Versa-Lock Universal Needle Connector
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K901046 FDA 510(k)
- FDA Product Code
- FPA 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 Versa-Lock Universal Needle Connector is a medical device classified under the product code FPA, designed as a universal connector for secure attachment and detachment of needles to infusion sets, ports, or other compatible tubing systems. It is engineered to reduce the risk of accidental needle sticks and improve usability in clinical settings by providing a reliable, twist-lock mechanism for needle connections. This connector is intended for general hospital use, ensuring compatibility with various infusion devices and reducing the need for multiple adapters.
The device is supplied as a reusable component, intended for integration into infusion systems or ports rather than standalone use. It is not described as sterile in the specifications, though its application in clinical settings may require adherence to sterile technique during use. The Versa-Lock connector is regulated under the FDA’s 510(k) clearance process, with a traditional review pathway, and holds clearance number K901046. No additional regulatory markings or MRI safety classifications are specified in the available data.
Frequently asked questions
Is the Versa-Lock Universal Needle Connector designed for single-use or can it be reused in clinical settings?
The Versa-Lock Universal Needle Connector is explicitly described as a reusable component, intended to be integrated into infusion systems or ports rather than used standalone. While it is not sterile by default, its design allows for repeated use in clinical settings as long as proper sterile technique is maintained during each application.
What types of infusion systems or devices is the Versa-Lock connector compatible with?
The Versa-Lock is engineered as a universal connector, meaning it is designed to securely attach and detach needles to infusion sets, ports, or compatible tubing systems. Its twist-lock mechanism ensures compatibility with a range of general hospital infusion devices, reducing the need for multiple adapters.
How is the Versa-Lock connector regulated, and what clearance number does it hold?
The Versa-Lock Universal Needle Connector is regulated under the FDA’s 510(k) clearance process, specifically through a traditional review pathway. It holds clearance number K901046 and is classified under product code FPA, with a decision of *Substantially Equivalent* (SESE) by the Orthopaedics (HO) Advisory Committee.
Does the Versa-Lock connector require sterilization before use, or can it be used as-is in clinical settings?
The device is not described as sterile in its specifications, meaning it is not pre-sterilized for direct patient use. However, since it is reusable and intended for integration into infusion systems, clinical staff must follow sterile technique protocols during each use to ensure safety and compliance with medical standards.
What is the primary purpose or clinical benefit of the twist-lock mechanism in this connector?
The twist-lock mechanism is designed to reduce the risk of accidental needle sticks and improve usability in clinical settings. By providing a secure, reliable attachment and detachment system, it minimizes the chance of misconnections or dislodgments, which can be critical during infusion therapy to maintain patient safety and treatment integrity.
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: VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTOR (K901046) — FDA 510(k ..., Vlv Associates, Inc. FDA 510 (k) Products (1986-1997), Home | VLV Associates, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K901046 | Class II | Active |
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Manufacturer
- Manufacturer
- Vlv Associates, Inc.
Sources (1)
- FDA 510(k) K901046 24 fields · synced Sep 20, 2026