# K030947: Alveolus Inc., TB-STS Tracheobronchial Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Alveolus, Inc.
- Decided: May 15, 2003 after 50 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: 2 generations back to K003173 (2001). 3 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963241: Ultraflex, Boston Scientific Corp (1996) Summary page 4.
- K003173: Aspire Covered Stent and Delivery Catheter, Vascular Architects, Inc. (2001) Summary page 4.
- K012544: Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery System, Vascular Architects, Inc. (2001) Summary page 4.

## Most influential descendants
- K033990: Alveolus Inc. TB-STS Tracheobronchial Stent System (2004), 15 descendants of its own
- K033053: Alveolus, TB-STS Tracheobronchial Stent System (2004), 15 descendants of its own
- 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

## Indications for use
The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K030947
Methodology: https://510kreport.com/methodology