# K170234: Endotracheal tube; Reinforced Endotracheal tube

- Pathway: 510(k) (Traditional)
- Applicant: Zhanjiang Star Enterprise Co., Ltd.
- Decided: Jan 17, 2018 after 357 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: 7 generations back to K903730 (1990). 21 ancestors in all.
No later device cites it as a predicate yet.
4 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140228: Disposable Tracheal Tube, Suzhou Weikang Medical Apparatus Co., Ltd. (2014) Summary page 5.
- K111406: Bever Reinforced Endotracheal Tube with Cuff (Oral/Nasal), Bever Reinforced Endotracheal Tube Without Cuff (Oral/Nasal), Hangzhou Bever Medical Devices Co., Ltd. (2012) Summary page 5.

## Indications for use
The Endotracheal tube is intended for oral or nasal intubation and for airway management. The Reinforced Endotracheal tube is intended for airway management by oral or nasal intubation of the trachea during anesthesia. It is a device inserted into the trachea through the mouth or nose to facilitate breathing and it may be used where the patient’s neck is likely to be moved of flexed or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.

Source page: https://510kreport.com/device/K170234
Methodology: https://510kreport.com/methodology