510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213969Substantially Equivalent

VisionAir Patient-Specific Airway Stent

New Cos Inc. dba Visionair Solutions, Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213969 is the FDA 510(k) clearance record for VisionAir Patient-Specific Airway Stent, a class II device, cleared for New Cos Inc. Dba Visionair Solutions on under FDA product code NWA (Prosthesis, Tracheal, Preformed/Molded). FDA's definition for product code NWA reads: "The device is intended to provide support to weakened or constricting airway walls". FDA records list one 510(k) clearance for New Cos Inc. Dba Visionair Solutions. As of , FDA records show no recalls naming K213969.

Clearance record

Decision date
Received
(291 days to decision)
Product code
NWA Prosthesis, Tracheal, Preformed/Molded
Regulation
21 CFR 878.3720
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
New Cos Inc. Dba Visionair Solutions 7100 Euclid Ave., Cleveland OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NWA

Trailing 12 months
1 clearance under product code NWA in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NWA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260