# K240127: PlumeSafe X5 Smoke Management System

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Aug 5, 2024 after 201 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: 4 generations back to K924732 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131402: Visiclear Smoke Evacuation System, Buffalo Filter Co., Inc. (2014) Summary page 5.

## Indications for use
The CONMED PlumeSafe® X5 TM Smoke Management 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/K240127
Methodology: https://510kreport.com/methodology