# K993582: Modification to Laser-Shield II

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Jan 20, 2000 after 90 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
No predicates in its family tree.
3 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)
- None. The FDA summary names its predicate without a number.
- (no number) Laser-Shield II: named in the summary without a submission number

## Most influential descendants
- K200761: Tenax Laser Resistant Endotracheal Tube (2020), 2 descendants of its own
- 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
Xomed Laser-Shield II 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 anesthesia gases or to overcome emergency obstruction of an airway.

Source page: https://510kreport.com/device/K993582
Methodology: https://510kreport.com/methodology