# K080105: Endotracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Chilecom Medical Devices Co., Ltd.
- Decided: Feb 13, 2009 after 396 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- 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 K961837 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
4 of 6 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 2.

## Indications for use
Endotracheal tubes is intended for oral or nasal.,inWtbation and for airway management.

Source page: https://510kreport.com/device/K080105
Methodology: https://510kreport.com/methodology