# K212403: Tracheal Stent System (Y-Shaped)

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Oct 30, 2021 after 89 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: 2 generations back to K894380 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971509: Endoxane, Novatech SA (1997) Summary page 5.

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

Source page: https://510kreport.com/device/K212403
Methodology: https://510kreport.com/methodology