# K032744: Alveolus Inc., TB-STS Tracheobronchial Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Alveolus, Inc.
- Decided: Nov 13, 2003 after 70 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- 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.

## Indications for use
t neoplasms

Source page: https://510kreport.com/device/K032744
Methodology: https://510kreport.com/methodology