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Stopcock & Luer Lock Plug

FDA 510(k)

Class II (US FDA 510(k))

510(k) K954970

by Medex, Inc.

Identifiers

510(k) Number
K954970 FDA 510(k)
FDA Product Code
FMG 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)

This device is a stopcock and Luer lock plug, classified as a Class II medical device under FDA regulations. Stopcocks are designed to control and direct fluid flow in intravenous (IV) administration systems, while Luer lock plugs are used to seal or close Luer ports to prevent contamination or leakage. The combination allows for secure fluid access and flow management in clinical settings.

The Stopcock and Luer Lock Plug is intended for use in general hospital environments, where it may be incorporated into IV sets or tubing systems. It is supplied as a reusable device and does not require sterilization between uses, as indicated by its regulatory submission. The device adheres to FDA 510(k) clearance (K954970) under the classification FMG, with no specific MRI safety or single-use restrictions noted. Sizes and specific model references (e.g., MX531-1LT, MX491T) are available as detailed in the regulatory submission.

Frequently asked questions

What clinical environments is this stopcock and Luer lock plug intended for use in?

This device is specifically designed for general hospital environments, where it can be integrated into intravenous (IV) sets or tubing systems to control and direct fluid flow. Its regulatory submission under the classification FMG (General and Plastic Surgery Devices) and medical specialty description as 'General Hospital' confirm its intended use in standard clinical settings.

Is this stopcock reusable, and if so, what are the implications for cleaning and sterilization?

Yes, this stopcock and Luer lock plug is supplied as a reusable device. According to the regulatory submission, it does not require sterilization between uses, which implies it is designed to be cleaned and maintained per standard hospital protocols for reusable medical devices. However, proper cleaning and handling are essential to prevent contamination or leakage.

What are the available sizes or model references for this stopcock and Luer lock plug?

The device is available in multiple sizes and model references, including examples like MX531-1LT and MX491T. These variations are detailed in the regulatory submission, allowing for flexibility in selecting the appropriate size or model for specific IV administration or tubing system requirements.

How was this device’s regulatory clearance determined, and what does that mean for its use?

The device received FDA 510(k) clearance (K954970) under the classification FMG, with a decision described as 'Substantially Equivalent' to a predicate device. This means the device was evaluated and found to have the same intended use, technological characteristics, and performance as a previously cleared product, ensuring its safety and effectiveness for controlling fluid flow in IV systems in general hospital settings.

Are there any restrictions on using this device in MRI environments?

The regulatory submission does not mention any specific MRI safety restrictions for this stopcock and Luer lock plug. This implies it is not intended for use in MRI environments unless explicitly tested and approved for such settings, which would require additional documentation or clearance beyond the current submission.

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: STOPCOCK & LUER LOCK PLUG (K954970) — FDA 510(k) | Innolitics, IV Administration - Stopcocks and Tubing - Medex Supply, Stopcock & Luer Lock Plug 510 (k) FDA Premarket Notification K954970 ..., fda.innolitics.com, NSN Parts by Medex Inc.: MX9006, MX920, MX9004, MX 492, MALE LUER LOCK ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medex, Inc.

Sources (1)

  • FDA 510(k) K954970 24 fields · synced Sep 19, 2026