Positive End Expiratory Pressure Valve
by Fraser Harlake, Inc. 510(k)
Active
510(k) K802943
Overview
The Positive End Expiratory Pressure Valve is a breathing attachment designed to maintain elevated airway pressure at the end of exhalation. It is classified as a Class II medical device and functions by ensuring alveoli remain partially inflated, improving oxygen exchange and lung compliance during mechanical ventilation.
This device is intended for use in anesthesia and critical care settings, connected to ventilators to deliver controlled positive pressure during exhalation. Supplied as a reusable component, it requires proper cleaning and sterilization between uses. The valve is regulated under FDA 510(k) clearance (K802943) and adheres to regulatory standards for respiratory therapy devices, including compliance with 21 CFR 868.5965.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK802943 | Date15 Jan 1981 | 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- Withdrawn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
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5965
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Fraser Harlake, Inc.
Questions
What clinical settings is this Positive End Expiratory Pressure Valve primarily intended for use in, and how does it function in those environments?
This valve is designed for anesthesia and critical care settings, where it connects to ventilators to deliver controlled positive pressure at the end of exhalation. By maintaining elevated airway pressure, it helps keep alveoli partially inflated, which improves oxygen exchange and lung compliance during mechanical ventilation—critical for patients requiring assisted breathing.
Is this device single-use or reusable, and what are the requirements for cleaning and sterilization if it is reusable?
The Positive End Expiratory Pressure Valve is supplied as a reusable component. To ensure safety and functionality between uses, it must undergo proper cleaning and sterilization as per manufacturer guidelines. This is essential to prevent contamination and maintain performance in clinical environments.
What regulatory pathway was followed for this device’s clearance, and which advisory committee was involved in the review process?
This device was cleared through the FDA’s 510(k) pathway under a traditional review process, with a decision of substantial equivalence (SESE). The review was conducted by the Anesthesiology (AN) Advisory Committee, reflecting its specialized use in anesthesia and critical care settings.
Are there multiple sizes or models of this valve, and how would one determine which variant is appropriate for a specific ventilator setup?
The device data lists multiple registration numbers (e.g., 3013557562, 3006061749), which may correspond to different models or variants. While specific sizing details aren’t provided, compatibility is typically determined by the ventilator’s interface specifications and manufacturer recommendations. Consulting the manufacturer’s documentation or support team is advised to ensure proper fit and function.