# K911154: Sun Medical Smoke/Fluid Evac Syst, Model Sfe-200

- Pathway: 510(k) (Traditional)
- Applicant: Sun Medical, Inc.
- Decided: Jul 26, 1991 after 133 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
No predicates in its family tree.
53 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K083211: Airseal Optical Trocar & Cannula System (2008), 51 descendants of its own
- K071571: Surgiquest Airseal Optical Trocar & Cannula System (2007), 36 descendants of its own
- K103692: Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000 (2011), 35 descendants of its own
- K143404: SurgiQuest AirSeal iFS System (2015), 27 descendants of its own
- K170784: Pneumoclear (2017), 17 descendants of its own

Source page: https://510kreport.com/device/K911154
Methodology: https://510kreport.com/methodology