# K261541: VisionAir Enhanced Stock Stent

- Pathway: 510(k) (Special)
- Applicant: VisionAir Solutions
- Decided: Jun 1, 2026 after 24 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: 3 generations back to K894380 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182743: Patient-Specific Airway Stent, New Cos, Inc. (2019) Summary page 5.

## Indications for use
The VisionAir Enhanced Stock Stent is indicated for the treatment of adults 222 years of age with symptomatic stenosis of the airway. The Enhanced Stock 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/K261541
Methodology: https://510kreport.com/methodology