# K173108: Smoklean

- Pathway: 510(k) (Traditional)
- Applicant: Sejong Medical Co., Ltd.
- Decided: May 18, 2018 after 231 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 K992361 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992361: Pall Surgiclear Laparoscopic Smoke Filtration System, Model CLSF1, Pall Medical (1999) Summary page 4.

## Indications for use
Smoklean is a passive smoke evacuation system which removes particles from surgical smoke generated in laparoscopic procedures while maintaining a clear field of vision.

Source page: https://510kreport.com/device/K173108
Methodology: https://510kreport.com/methodology