# K110269: Well Lead Endotracheal Tube with Evacuation Lumen-Oral

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Co., Ltd.
- Decided: Aug 26, 2011 after 211 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K961837 (1996). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
5 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042683: Well Lead Endotracheal Tube, Well Lead Medical Instruments (2005) Summary page 1.
- K090352: Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal Tubes, Covidien (2009) Summary page 1.

## Most influential descendants
- K190878: Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff (2020), 0 descendants of its own
- K182739: Endotracheal Tube with Evacuation Lumen (2019), 0 descendants of its own

## Recalls of this device
- Feb 26, 2024 · Class I · Z-1876-2024: Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were als
- Jun 2, 2016 · Class II · Z-2243-2016: Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinki

## Indications for use
The device is intended for Oral intiibation and drainage of the subglottic space for airway management.

Source page: https://510kreport.com/device/K110269
Methodology: https://510kreport.com/methodology