# K202204: Tracheal Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Sep 1, 2021 after 392 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: 6 generations back to K003173 (2001). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082284: Aero Tracheobronchial Stent Technology System, Alveolus, Inc. (2008) Summary page 5.

## Most influential descendants
- K220424: Through the Scope Tracheal Stent System (2022), 0 descendants of its own

## Indications for use
The Tracheal Stent System (OTW) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.

Source page: https://510kreport.com/device/K202204
Methodology: https://510kreport.com/methodology