# K983298: Buffalo Filter Virosafe Erbium:Yag Filter - #VSEYAG1-4 Buffalo Filter Virosafe Erbium:Yag Prefilter - #BFEYAG04PF

- Pathway: 510(k) (Traditional)
- Applicant: Buffalo Filter Co., Inc.
- Decided: Aug 16, 1999 after 329 days
- Product code: FYD (Apparatus, Exhaust, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.5070
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- May 25, 2022 · Class III · Z-1795-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
The Indications for Use of the ViroSafe EY Filter and Buffalo EY Prefilter are for the removal and filtration of the smoke and incidental fluid produced during laser surgery, electrosurgery, or other smoke plume producing devices. This device is not intended for contact with the patient. It is intended to be used during either open or endoscopic surgical procedures.

Source page: https://510kreport.com/device/K983298
Methodology: https://510kreport.com/methodology