# K200761: Tenax Laser Resistant Endotracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Bryan Medical, Inc.
- Decided: Nov 25, 2020 after 246 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: 1 generation back to K993582 (2000). 1 ancestor in all.
2 later devices descend 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)
- K993582: Modification to Laser-Shield II, Xomed, Inc. (2000) Summary page 4.

## Most influential descendants
- K213028: Tenax Laser Resistant Endotracheal Tube (2021), 1 descendant of its own
- 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) or KTP (532 nm) 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/K200761
Methodology: https://510kreport.com/methodology