# K053464: Service Manager SM40SE

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Integrated Systems, Canada, Ulc
- Decided: Jun 6, 2006 after 175 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: 1 generation back to K924732 (1993). 2 ancestors in all.
6 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)
- K955750: Teletom, Berchtold Holding GmbH (1996) Summary page 1.
- K924732: Porta Plumesafe (TM) 601 Smoke Evacuation System, Buffalo Filter Co., Inc. (1993) Summary page 1.

## Most influential descendants
- K091139: Conmed Aer Defense Smoke Evacuator (2009), 5 descendants of its own
- 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

## Indications for use
The intended use for the SM40SE console is to position and manage devices such as medical gas, high and low voltage electrical, communication and accessories such as equipment shelves, drawers, IVpoles and smoke evacuation units. The smoke plume evacuator integrated into the SM40SE is intended for the evacuation and filtration of smoke plume and odor generated during laser or electrosurgery.

Source page: https://510kreport.com/device/K053464
Methodology: https://510kreport.com/methodology