# K973610: Skyval

- Pathway: 510(k) (Traditional)
- Applicant: Pyramid Air Systems
- Decided: Dec 19, 1997 after 88 days
- Product code: FYD (Apparatus, Exhaust, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.5070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SKYVAC is a central smoke evacuation system. This system is intended to be used by medical personnel for the purpose of removing smoke generated during operating procedures by laser and electro-surgical units.

Source page: https://510kreport.com/device/K973610
Methodology: https://510kreport.com/methodology