Cleared Special

K261541 - VisionAir Enhanced Stock Stent

K261541 is an FDA 510(k) clearance for VisionAir Enhanced Stock Stent, manufactured by VisionAir Solutions. The device is a Class 2 Anesthesiology device with product code NWA cleared through the Special 510(k) pathway after a 24-day FDA review.

K261541 · VisionAir Solutions · Anesthesiology device
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Jun 2026
Decision
24d
Days
Class 2
Risk

K261541 is an FDA 510(k) clearance for the VisionAir Enhanced Stock Stent. Classified as Prosthesis, Tracheal, Preformed/molded (product code NWA), Class II - Special Controls.

Submitted by VisionAir Solutions (Akron, US). The FDA issued a Cleared decision on June 1, 2026 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 878.3720 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all VisionAir Solutions devices

FDA 510(k) Submission Details - K261541

510(k) Number K261541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2026
Decision Date June 01, 2026
Days to Decision 24 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 140d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

NWA Device Classification - Class 2, Special Controls

Product Code NWA Prosthesis, Tracheal, Preformed/molded
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3720
Definition The Device Is Intended To Provide Support To Weakened Or Constricting Airway Walls.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - NWA Prosthesis, Tracheal, Preformed/molded

Devices cleared under the same product code (NWA) and FDA review panel - the closest regulatory comparables to K261541.
TRACHEOBRONXANE™ DUMON®
K243126 · Novatech SA · Oct 2024
VisionAir Patient-Specific Airway Stent
K213969 · New Cos Inc. Dba Visionair Solutions · Oct 2022
Patient-Specific Airway Stent
K182743 · New Cos, Inc. · Oct 2019
ENDOXANE
K971509 · Novatech SA · Aug 1997
HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES
K873742 · Hood Laboratories · Oct 1987