# K062511: Aero Tracheobronchial Stent System, Model 90129-2XX

- Pathway: 510(k) (Traditional)
- Applicant: Alveolus, Inc.
- Decided: Jan 31, 2007 after 156 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: 4 generations back to K003173 (2001). 9 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 24 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 1.
- K033053: Alveolus, TB-STS Tracheobronchial Stent System, Alveolus, Inc. (2004) Summary page 1.
- K033990: Alveolus Inc. TB-STS Tracheobronchial Stent System, Alveolus, Inc. (2004) Summary page 1.
- K963241: Ultraflex, Boston Scientific Corp (1996) Summary page 1.
- K013266: Rusch Polyflex Stent Kit, Rusch Intl. (2001) Summary page 1.
- K971509: Endoxane, Novatech SA (1997) Summary page 2.

## Most influential descendants
- 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
- K233939: Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (2024), 1 descendant of its own

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

Source page: https://510kreport.com/device/K062511
Methodology: https://510kreport.com/methodology