# K082284: Aero Tracheobronchial Stent Technology System

- Pathway: 510(k) (Traditional)
- Applicant: Alveolus, Inc.
- Decided: Nov 20, 2008 after 101 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: 5 generations back to K003173 (2001). 10 ancestors in all.
11 later devices descend from it; 5 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)
- K062511: Aero Tracheobronchial Stent System, Model 90129-2XX, Alveolus, Inc. (2007) 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
- 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
- K202204: Tracheal Stent System (2021), 1 descendant of its own

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

Source page: https://510kreport.com/device/K082284
Methodology: https://510kreport.com/methodology