0-20 Cm H20 Peep Valve
by Cheen Houng Ent. Co., Ltd. 510(k)
Active
510(k) K981415
Overview
The 0–20 cm H₂O PEEP Valve is a Positive End-Expiratory Pressure (PEEP) attachment designed for manual resuscitators. It provides adjustable airway pressure support during mechanical ventilation or resuscitation by maintaining a set level of positive pressure at the end of exhalation, improving oxygenation and lung compliance in patients.
This single-use, non-sterile device is intended for use in anesthesia and critical care settings. It is classified as a Class II medical device under FDA regulation 868.5965 and is supplied as a disposable component for manual ventilators. The device requires no special storage conditions beyond those specified by the manufacturer and is regulated under the FDA 510(k) clearance (K981415) with a product code of BYE.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK981415 | Date14 Jul 1998 | 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- Withdrawn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
- BYE
- FDA applicant
- Cheen Houng Ent. Co. , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5965
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Cheen Houng Ent. Co., Ltd.
Questions
What clinical settings is this PEEP valve designed for, and how does it function in those environments?
The 0–20 cm H₂O PEEP Valve is specifically designed for use in anesthesia and critical care settings, where patients require controlled airway pressure during mechanical ventilation or resuscitation. It attaches to manual resuscitators to provide adjustable Positive End-Expiratory Pressure (PEEP), maintaining a set level of positive pressure at the end of exhalation. This helps improve oxygenation and lung compliance, particularly in patients with compromised breathing or those requiring assisted ventilation.
Is this device single-use or reusable, and what are the implications for sterility and handling?
This PEEP valve is single-use only and is non-sterile, meaning it should not be reused or sterilized for repeated use. As a disposable component, it must be discarded after one use to ensure patient safety and prevent contamination. Proper handling and disposal protocols should follow manufacturer guidelines to avoid cross-contamination.
What pressure range does this valve support, and how is it adjusted?
The valve supports an adjustable pressure range of 0 to 20 cm H₂O. The adjustment mechanism allows clinicians to set the desired PEEP level, ensuring consistent positive pressure at the end of exhalation during ventilation or resuscitation. The exact adjustment method is detailed in the manufacturer’s instructions for use.
How should this device be stored, and are there any special conditions required?
The device does not require special storage conditions beyond those specified by the manufacturer. Since it is single-use and non-sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the manufacturer’s packaging for specific storage instructions to maintain functionality and integrity before use.
What regulatory pathway was followed for this device’s approval, and what does that mean for its use?
This PEEP valve was cleared through the FDA 510(k) pathway (K981415), with a classification as a Class II medical device under regulation 868.5965. The clearance indicates it was determined to be substantially equivalent to a legally marketed predicate device, meaning it meets FDA safety and effectiveness standards for its intended use in manual resuscitators. The product code BYE further categorizes it as an attachment for breathing support.