SafePort Manifold (or Stopcock)
by Elcam Medical ACAL 510(k)
Active
510(k) K211204
Overview
The SafePort Manifold (or Stopcock) is a medical device classified as a stopcock, intravenous (I.V.) set component, designed for fluid pathway control in clinical environments. It functions as a multi-port connector to regulate the flow of gases, liquids, or medications between different lines or systems, ensuring precise administration while minimizing leaks and contamination risks. Commonly used in anesthesia delivery systems, it integrates valves to enhance safety and operational efficiency during procedures.
This device is supplied as a reusable Class II medical product, intended for use in general hospital settings. It is cleared under FDA 510(k) (K211204) as substantially equivalent to predicate devices, adhering to regulation 21 CFR 880.5440. The manifold is designed for sterile or semi-critical applications, requiring proper cleaning and maintenance protocols to ensure functionality and patient safety. Multiple reference codes (e.g., 3009211636, 1000112877) identify compatible configurations, including variations in port sizes and valve configurations.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211204 | Date15 Sep 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- SafePort(TM) Manifold (or Stopcock)
- 510(k) Number
- FDA Product Code
- FMG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Elcam Medical ACAL
Questions
What is the SafePort™ Manifold Stopcock used for?
The SafePort™ Manifold Stopcock is designed to control the flow of gases, liquids, or medications between multiple lines or systems in clinical environments. It is particularly useful in anesthesia delivery systems to ensure precise administration while minimizing leaks and contamination risks. The integrated valves enhance safety and operational efficiency during procedures.
Is the SafePort™ Manifold Stopcock reusable or single-use?
The SafePort™ Manifold Stopcock is a reusable medical device. As a Class II reusable product, it requires proper cleaning and maintenance protocols to ensure functionality and patient safety, particularly since it is intended for sterile or semi-critical applications.
What are the key reference codes or configurations for the SafePort™ Manifold Stopcock?
The SafePort™ Manifold Stopcock comes in multiple configurations, each identified by specific reference codes such as 3009211636, 1000112877, and others. These variations include differences in port sizes and valve configurations to accommodate diverse clinical needs. The exact reference code determines compatibility with specific systems.
How should the SafePort™ Manifold Stopcock be stored?
Since the SafePort™ Manifold Stopcock is reusable and intended for sterile or semi-critical applications, it must be stored in a clean, dry environment to prevent contamination. Follow manufacturer guidelines for proper cleaning, disinfection, and maintenance procedures to ensure it remains functional and safe for repeated use.
What regulatory pathway does the SafePort™ Manifold Stopcock follow?
The SafePort™ Manifold Stopcock is cleared under the FDA 510(k) pathway (K211204) as substantially equivalent to predicate devices. It adheres to regulation 21 CFR 880.5440 and is classified as a reusable Class II medical device, intended for use in general hospital settings.