# K140472: Bonastent Tracheal / Bronchial

- Pathway: 510(k) (Traditional)
- Applicant: Endochoice, Inc.
- Decided: Oct 17, 2014 after 234 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: 9 generations back to K923119 (1992). 55 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 57 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 5.
- K092144: Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare, Models Befg and Befr, Endochoice, Inc. (2010) Summary page 5.
- K093003: Bonastent Biliary, Endochoice, Inc. (2010) Summary page 5.

## Most influential descendants
- K201342: HANAROSTENT Trachea/Bronchium (CCC) (2020), 0 descendants of its own

## Indications for use
The BONASTENT® Tracheal/Bronchial Stent System is indicated for the treatment of tracheobronchial strictures caused by malignant neoplasms.

Source page: https://510kreport.com/device/K140472
Methodology: https://510kreport.com/methodology