# K251794: Tenax® Laser Resistant Endotracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Bryan Medical, Inc.
- Decided: Sep 3, 2026 after 448 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 K993582 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213028: Tenax Laser Resistant Endotracheal Tube, Bryan Medical, Inc. (2021) Summary page 5.

## Indications for use
The Tenax® Laser Resistant Endotracheal Tube is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10.60 microns), KTP (532 nm) or Blue (445nm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthetic gases or to overcome emergency obstruction of an airway. The device is intended for use in adult patients.

Source page: https://510kreport.com/device/K251794
Methodology: https://510kreport.com/methodology