# K142538: LiNA SafeAir Smoke Pencil

- Pathway: 510(k) (Special)
- Applicant: Lina Medical Aps
- Decided: Oct 6, 2014 after 27 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: 3 generations back to K791137 (1979). 9 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120454: Safeair Smoke Pencil,, Lna Medical Aps (2012) Summary page 5.

## Most influential descendants
- K143145: SafeAir Smoke Pencil (2014), 4 descendants of its own
- K153679: Stryker Neptune E-SEP Smoke Evacuation Pencil (2016), 3 descendants of its own
- K160693: Neptune E-SEP Smoke Evacuation Pencil (2016), 2 descendants of its own
- K261959: Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) (2026), 0 descendants of its own
- K182354: SafeAir Telescopic Smoke Pencil (2018), 0 descendants of its own

## Indications for use
The LiNA SafeAir Smoke Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

Source page: https://510kreport.com/device/K142538
Methodology: https://510kreport.com/methodology