FDA Product Code NWA: Prosthesis, Tracheal, Preformed/molded
The Device Is Intended To Provide Support To Weakened Or Constricting Airway Walls.
Leading manufacturers include New Cos, Inc., New Cos Inc. Dba Visionair Solutions and Novatech SA.
7
Total
7
Cleared
138d
Avg days
1987
Since
Growing category -
2 submissions in the last 2 years
vs 1 in the prior period
Review times improving: avg
27d
recently vs 183d historically
FDA 510(k) Cleared Prosthesis, Tracheal, Preformed/molded Devices (Product Code NWA)
7 devices
Cleared
Jun 01, 2026
VisionAir Enhanced Stock Stent
VisionAir Solutions
Anesthesiology
24d
Cleared
Oct 29, 2024
TRACHEOBRONXANE™ DUMON®
Novatech SA
Anesthesiology
29d
Cleared
Oct 07, 2022
VisionAir Patient-Specific Airway Stent
New Cos Inc. Dba Visionair Solutions
Anesthesiology
291d
Cleared
Oct 23, 2019
Patient-Specific Airway Stent
New Cos, Inc.
Anesthesiology
390d
About Product Code NWA - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code NWA since 1987, with 7 receiving FDA clearance (average review time: 138 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - NWA Product Code
Recent submissions under NWA have taken an average of 27 days to reach a decision - down from 183 days historically, suggesting improved FDA processing for this classification.
NWA devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →