# K121048: Ultraflex Tracheobronchial Stent System- Sterile Uncovered

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 3, 2012 after 119 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: 7 generations back to K003173 (2001). 20 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963241: Ultraflex, Boston Scientific Corp (1996) Summary page 1.
- K012883: Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System, Boston Scientific Corp (2001) Summary page 2.
- K091816: Ultraflex Esophageal NG Stent System, Boston Scientific Corporation (2009) Summary page 1.
- K083625: Aero DV Tracheobronchial Stent System, Alveolus, Inc. (2009) Summary page 1.
- K082284: Aero Tracheobronchial Stent Technology System, Alveolus, Inc. (2008) Summary page 1.

## Most influential descendants
- K130004: Ultraflex Esophageal NG Stent System (2013), 2 descendants of its own
- K233939: Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (2024), 1 descendant of its own
- K141584: Ultraflex Tracheobronchial Covered Stent System (2014), 1 descendant of its own
- K261978: WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (2026), 0 descendants of its own
- K230269: Ultraflex™ Tracheobronchial Stent System (2023), 0 descendants of its own

## Indications for use
The UltraflexTL{ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K121048
Methodology: https://510kreport.com/methodology