Water Column Relief Valve
by Icn Pharmaceuticals, Inc. 510(k)
Active
510(k) K904398
Overview
The Water Column Relief Valve is a pressure-relief device designed for use in anesthesia delivery systems. It regulates and releases excess pressure within the breathing circuit to prevent overinflation of the lungs during mechanical ventilation or manual resuscitation.
This device is intended for single-use in clinical settings, such as operating rooms or emergency resuscitation areas. Supplied sterile and packaged individually, it complies with FDA 510(k) clearance under K904398, with a traditional review process through the Anesthesiology Advisory Committee. No MRI safety information or reusable specifications are provided in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904398 | Date9 Jul 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CAF
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Icn Pharmaceuticals, Inc.
Questions
What clinical scenarios is the Water Column Relief Valve designed to protect against during anesthesia delivery or resuscitation?
The Water Column Relief Valve is specifically designed to prevent overinflation of the lungs by regulating and releasing excess pressure within the breathing circuit during mechanical ventilation or manual resuscitation. This makes it critical in scenarios where controlled lung inflation is essential, such as in operating rooms or emergency resuscitation settings.
Is this device reusable, or is it intended for single-use only? How does this affect its clinical handling?
The Water Column Relief Valve is explicitly intended for single-use only in clinical settings. This means it must be discarded after one use to maintain sterility and safety, requiring proper disposal protocols to avoid reuse or contamination. The sterile packaging ensures it remains uncontaminated until first use.
How is the Water Column Relief Valve supplied, and what does this mean for storage and preparation before use?
The device is supplied sterile and individually packaged, meaning each unit is sealed and ready for immediate clinical use without additional sterilization. Storage should follow manufacturer guidelines to preserve sterility—typically in a clean, dry environment away from direct sunlight or extreme temperatures until use.
What regulatory pathway was followed for FDA clearance, and how does this relate to its safety and approval status?
The Water Column Relief Valve received FDA 510(k) clearance (K904398) through a traditional review process with input from the Anesthesiology Advisory Committee. This pathway confirms the device meets FDA standards for safety and effectiveness as a pressure-relief mechanism in anesthesia systems, ensuring compliance with regulatory requirements for its intended use.