# K033053: Alveolus, TB-STS Tracheobronchial Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Alveolus, Inc.
- Decided: Feb 25, 2004 after 149 days
- Product code: JCT (Prosthesis, Tracheal, Expandable)
- Device class: 2
- Regulation: 21 CFR 878.3720
- 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 K003173 (2001). 7 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030947: Alveolus Inc., TB-STS Tracheobronchial Stent System, Alveolus, Inc. (2003) Summary page 4.
- K013266: Rusch Polyflex Stent Kit, Rusch Intl. (2001) Summary page 4.
- K971509: Endoxane, Novatech SA (1997) Summary page 4.
- K963241: Ultraflex, Boston Scientific Corp (1996) Summary page 5.

## Most influential descendants
- K062511: Aero Tracheobronchial Stent System, Model 90129-2XX (2007), 14 descendants of its own
- K082284: Aero Tracheobronchial Stent Technology System (2008), 11 descendants of its own
- K083625: Aero DV Tracheobronchial Stent System (2009), 6 descendants of its own
- K121048: Ultraflex Tracheobronchial Stent System- Sterile Uncovered (2012), 5 descendants of its own
- K130004: Ultraflex Esophageal NG Stent System (2013), 2 descendants of its own

## Indications for use
The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures and airway compression (stenosis) produced by malignant neoplasms. Because the device is removable it may also be used to treat conditions such as tracheo-esophageal fistula resulting from malignancies and strictures resulting from surgical anastomosis of the airway in patients with malignancies.

Source page: https://510kreport.com/device/K033053
Methodology: https://510kreport.com/methodology