# K091139: Conmed Aer Defense Smoke Evacuator

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: May 5, 2009 after 15 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: 2 generations back to K924732 (1993). 3 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K924732: Porta Plumesafe (TM) 601 Smoke Evacuation System, Buffalo Filter Co., Inc. (1993) Summary page 1.
- K053464: Service Manager SM40SE, Conmed Integrated Systems, Canada, Ulc (2006) Summary page 1.

## Most influential descendants
- K131402: Visiclear Smoke Evacuation System (2014), 4 descendants of its own
- 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 CONMED Aer Defense Smoke Evacuator is designed to remove smoke, aerosols and mitigate odors produced by surgical smoke during electrosurgical procedures.

Source page: https://510kreport.com/device/K091139
Methodology: https://510kreport.com/methodology