# K140382: Aeromini Tracheobronchial Stent Technology

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Nov 25, 2014 after 284 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 4.

## Most influential descendants
- K181200: AEROmini Tracheobronchial Stent System (2018), 0 descendants of its own

## Indications for use
The MERIT ENDOTEK AEROmMmini Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K140382
Methodology: https://510kreport.com/methodology