# K182743: Patient-Specific Airway Stent

- Pathway: 510(k) (Traditional)
- Applicant: New Cos, Inc.
- Decided: Oct 23, 2019 after 390 days
- Product code: NWA (Prosthesis, Tracheal, Preformed/Molded)
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 5 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 4.

## Most influential descendants
- K261541: VisionAir Enhanced Stock Stent (2026), 0 descendants of its own
- K213969: VisionAir Patient-Specific Airway Stent (2022), 0 descendants of its own

## Indications for use
The Patient-Specific Airway Stent is indicated for the treatment of adults ≥22 years of age with symptomatic stenosis of the airway. The silicone stent is intended for implantation into the airway by a physician using the recommended deployment system or an equivalent rigid bronchoscope and stent placement system that accepts the maximum stent diameter being placed. The stent is intended to be in the patient up to 12 months after initial placement.

Source page: https://510kreport.com/device/K182743
Methodology: https://510kreport.com/methodology