# K131402: Visiclear Smoke Evacuation System

- Pathway: 510(k) (Traditional)
- Applicant: Buffalo Filter Co., Inc.
- Decided: Mar 3, 2014 after 292 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
Longest line of descent: 3 generations back to K924732 (1993). 4 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091139: Conmed Aer Defense Smoke Evacuator, Conmed Corporation (2009) Summary page 2.
- K924732: Porta Plumesafe (TM) 601 Smoke Evacuation System, Buffalo Filter Co., Inc. (1993) Summary page 2.

## Most influential descendants
- K240127: PlumeSafe X5 Smoke Management System (2024), 0 descendants of its own
- K233789: 8Q10 Surclear Smoke Plume Evacuation System (2024), 0 descendants of its own
- K182224: SafeAir Smoke Evacuator compact (2019), 0 descendants of its own
- K142335: RapidVac Smoke Evacuator System (2015), 0 descendants of its own

## Indications for use
The VlsiClear Smoke Evacuation System is designed to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures

Source page: https://510kreport.com/device/K131402
Methodology: https://510kreport.com/methodology