# K213028: Tenax Laser Resistant Endotracheal Tube

- Pathway: 510(k) (Special)
- Applicant: Bryan Medical, Inc.
- Decided: Oct 21, 2021 after 30 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: 2 generations back to K993582 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200761: Tenax Laser Resistant Endotracheal Tube, Bryan Medical, Inc. (2020) Summary page 4.

## Most influential descendants
- K251794: Tenax® Laser Resistant Endotracheal Tube (2026), 0 descendants of its own

## 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 Laser (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.

Source page: https://510kreport.com/device/K213028
Methodology: https://510kreport.com/methodology