Cleared Traditional

K213969 - VisionAir Patient-Specific Airway Stent (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213969 · New Cos Inc. Dba Visionair Solutions · Anesthesiology device
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Oct 2022
Decision
291d
Days
Class 2
Risk

K213969 is an FDA 510(k) clearance for the VisionAir Patient-Specific Airway Stent. Classified as Prosthesis, Tracheal, Preformed/molded (product code NWA), Class II - Special Controls.

Submitted by New Cos Inc. Dba Visionair Solutions (Cleveland, US). The FDA issued a Cleared decision on October 7, 2022 after a review of 291 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 878.3720 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all New Cos Inc. Dba Visionair Solutions devices

Submission Details

510(k) Number K213969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2021
Decision Date October 07, 2022
Days to Decision 291 days
Submission Type Traditional
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
152d slower than avg
Panel avg: 139d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.