# K120454: Safeair Smoke Pencil,

- Pathway: 510(k) (Traditional)
- Applicant: Lna Medical Aps
- Decided: Dec 7, 2012 after 297 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 K791137 (1979). 8 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103375: Plumepen Integrated Smoke Evacuation Pencil, Medtek Devices, Inc. (2011) Summary page 1.
- K961616: Telescoping Penevac (Modification), I.C Medical, Inc. (1996) Summary page 1.
- K081634: Conmed Goldvac Integrated Smoke Evacuation Pencil, Conmed Corporation (2008) Summary page 1.

## Most influential descendants
- K142538: LiNA SafeAir Smoke Pencil (2014), 5 descendants of its own
- 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

## Indications for use
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/K120454
Methodology: https://510kreport.com/methodology