510(k) · Cleared
Recalled · Class III · 2022Buffalo Filter Virosafe Erbium:Yag Filter - #VSEYAG1-4 Buffalo Filter Virosafe Erbium:Yag Prefilter - #BFEYAG04PF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Buffalo Filter Co., Inc. · FYD Apparatus, Exhaust, Surgical
Cleared on Aug 16, 1999 after a 329-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Aug 16, 1999
- Review
- 329 days
- Class
- Class II
- Product code
- FYD
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FYD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FYD device
- #1 K240127 PlumeSafe X5 Smoke Management Systemscore 8.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class III | Z-1795-2022 | Environmental control | 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. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All FYD devicesFYD Apparatus, Exhaust, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FYD
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FYD
71in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYD
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FYD
15in 2025
MAUDE reports naming product code FYD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 1 | 39 |
| 2011 | 0 | — | 0 | 150 |
| 2012 | 0 | — | 0 | 120 |
| 2013 | 0 | — | 0 | 142 |
| 2014 | 1 | — | 0 | 71 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 3 | 71 | 0 | 11 |
| 2020 | 1 | — | 0 | 11 |
| 2021 | 1 | — | 0 | 20 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K983298 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983298: Buffalo Filter Virosafe Erbium:Yag Filter - #VSEYAG1-4 Buffalo Filter Virosafe Erbium:Yag Prefilter - #BFEYAG04PF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983298
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026