# K143145: SafeAir Smoke Pencil

- Pathway: 510(k) (Special)
- Applicant: Lina Medical Aps
- Decided: Dec 4, 2014 after 31 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K791137 (1979). 10 ancestors in all.
4 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)
- K142538: LiNA SafeAir Smoke Pencil, Lina Medical Aps (2014) Summary page 5.
- K120454: Safeair Smoke Pencil,, Lna Medical Aps (2012) Summary page 8.

## Most influential descendants
- 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

## Recalls of this device
- Jan 8, 2025 · Class II · Z-1138-2025: Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
- Dec 3, 2024 · Class II · Z-0807-2025: Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction 
- Oct 4, 2024 · Class II · Z-0368-2025: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in
- Oct 4, 2024 · Class II · Z-0365-2025: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in
- Oct 4, 2024 · Class II · Z-0367-2025: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in
- Oct 4, 2024 · Class II · Z-0369-2025: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in
- Oct 4, 2024 · Class II · Z-0370-2025: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in
- Oct 4, 2024 · Class II · Z-0366-2025: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in

## Indications for use
The 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/K143145
Methodology: https://510kreport.com/methodology