# K201342: HANAROSTENT Trachea/Bronchium (CCC)

- Pathway: 510(k) (Traditional)
- Applicant: M.I.Tech Co., Ltd.
- Decided: Dec 31, 2020 after 225 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: 10 generations back to K923119 (1992). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140472: Bonastent Tracheal / Bronchial, Endochoice, Inc. (2014) Summary page 4.

## Indications for use
The HANAROSTENT@ Trachea/Bronchium (CCC) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.

Source page: https://510kreport.com/device/K201342
Methodology: https://510kreport.com/methodology