# K152842: Wallstent RP Endoprosthesis Tracheobronchial, Wallstent  Endoprosthesis Tracheobronchial

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: May 19, 2016 after 233 days
- Product code: JCT (Prosthesis, Tracheal, Expandable)
- Device class: 2
- Regulation: 21 CFR 878.3720
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K923119 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992510: Wallstent Tracheobronchial Endoprosthesis and Unistep Plus Delivery System, Boston Scientific Corp (1999) Summary page 4.

## Recalls of this device
- Mar 7, 2018 · Class II · Z-3036-2018: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- Mar 7, 2018 · Class II · Z-3040-2018: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- Mar 7, 2018 · Class II · Z-3037-2018: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- Mar 7, 2018 · Class II · Z-3035-2018: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- Mar 7, 2018 · Class II · Z-3039-2018: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

## Indications for use
The WALLSTENT RP Endoprosthesis and WALLSTENT Endoprosthesis Tracheobronchial are indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K152842
Methodology: https://510kreport.com/methodology