# K213969: VisionAir Patient-Specific Airway Stent

- Pathway: 510(k) (Traditional)
- Applicant: New Cos Inc. Dba Visionair Solutions
- Decided: Oct 7, 2022 after 291 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 4.

## Indications for use
The VisionAir 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/K213969
Methodology: https://510kreport.com/methodology