Skyval Surgical Exhaust Apparatus
by Pyramid Air Systems 510(k)
Active
510(k) K973610
Overview
The Skyval is an Apparatus, Exhaust, Surgical designed for surgical ventilation and smoke evacuation. It removes airborne contaminants, including surgical smoke and fumes, from operating rooms to improve air quality and reduce exposure to healthcare personnel and patients during procedures.
This device is supplied as a reusable Class II medical product, regulated under FDA 510(k) clearance (K973610) and classified under product code FYD. It is intended for use in surgical settings and adheres to regulatory standards for surgical exhaust systems. No MRI safety or sterility specifications are noted in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973610 | Date19 Dec 1997 | 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- Withdrawn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
- Full name
- Skyval
- 510(k) Number
- FDA Product Code
- FYD
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.5070
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Skyval primarily used for in a surgical setting and how does it improve the environment for patients and staff?
The Skyval is designed as an Apparatus, Exhaust, Surgical to remove airborne contaminants like surgical smoke and fumes during procedures. It actively ventilates operating rooms, improving air quality by reducing exposure to harmful particles for both patients and healthcare personnel.
Is the Skyval a single-use or reusable device, and what does that mean for maintenance?
The Skyval is a reusable Class II medical device, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. This design allows hospitals to invest in a durable system rather than replacing it after each procedure.
What regulatory pathway does the Skyval follow, and what does that indicate about its compliance?
The Skyval follows the FDA 510(k) clearance pathway (K973610) and is classified under product code FYD, indicating it is regulated as a Class II device. This means it has undergone a premarket submission to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets FDA safety and performance standards.
Are there different sizes or models of the Skyval, and how might that affect its application in different operating rooms?
The provided data lists multiple FEI numbers, which typically correspond to different configurations or variants of the device. While exact specifications (e.g., airflow capacity, ducting options) aren’t detailed here, these variations likely allow the Skyval to be tailored for different room sizes, surgical specialties (e.g., plastic surgery), or ventilation requirements, ensuring compatibility with various OR layouts.
How should the Skyval be stored, and are there any special considerations for its longevity or performance?
Since the Skyval is a reusable device, storage should follow manufacturer guidelines for Class II medical equipment—typically in a clean, dry environment away from direct sunlight or extreme temperatures. While no sterility specifications are noted, proper maintenance (e.g., periodic inspections, filter replacements) is critical to sustain performance and prevent contamination, as outlined in the device’s operational manual.