# K051416: Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner Cannula

- Pathway: 510(k) (Special)
- Applicant: Mallinckrodt Medical
- Decided: Jun 16, 2005 after 15 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- 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 K003315 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003315: Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula, Mallinckrodt, Inc. (2000) Summary page 1.

## Indications for use
The Mallinckrodt Inc. Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula are intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff is intended to establish a seal between the tracheal wall and the tracheostomy tube. This device is intended to be a component of a life-sustaining device to be used with adult patients.

Source page: https://510kreport.com/device/K051416
Methodology: https://510kreport.com/methodology