# K223932: SafeAir combi (SFR-combi-US)

- Pathway: 510(k) (Traditional)
- Applicant: Lina Medical Aps
- Decided: Apr 26, 2023 after 117 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K944602 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143161: Force FX-8(S), Force FX-8C (S), Force FX-8CA (S), Covidien (2014) Summary page 4.

## Indications for use
The SafeAir Combi is an electrosurgical generator containing an integrated surgical smoke evacuator. The unit is intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. When used with an electrosurgical pencil capable of surgical smoke evacuation, the console is also intended to remove and filtrate smoke generated during electrosurgical procedures.

Source page: https://510kreport.com/device/K223932
Methodology: https://510kreport.com/methodology