# K182354: SafeAir Telescopic Smoke Pencil

- Pathway: 510(k) (Traditional)
- Applicant: Lina Medical Aps
- Decided: Dec 14, 2018 after 107 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K791137 (1979). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160693: Neptune E-SEP Smoke Evacuation Pencil, Stryker Corporation (2016) Summary page 5.

## Recalls of this device
- Mar 26, 2020 · Class II · Z-1807-2020: Due to a distribution error, product from the affected lot was shipped expired.
- Jan 13, 2020 · Class II · Z-1099-2020: Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
- Jan 13, 2020 · Class II · Z-1098-2020: Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
- Jan 13, 2020 · Class II · Z-1097-2020: Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.

## Indications for use
SafeAir Telescopic 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/K182354
Methodology: https://510kreport.com/methodology