Cleared Traditional

K251584 - Medical Mesh Nebulizer (AirICU Max+) (FDA 510(k) Clearance)

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

K251584 · AIRICU, Inc. · Anesthesiology device
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Mar 2026
Decision
293d
Days
Class 2
Risk

K251584 is an FDA 510(k) clearance for the Medical Mesh Nebulizer (AirICU Max+). Classified as Ventilator-compatible Nebulizer (product code SFP), Class II - Special Controls.

Submitted by AIRICU, Inc. (City Of Industry, US). The FDA issued a Cleared decision on March 12, 2026 after a review of 293 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 AIRICU, Inc. devices

Submission Details

510(k) Number K251584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2025
Decision Date March 12, 2026
Days to Decision 293 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 139d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SFP Ventilator-compatible Nebulizer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
Definition The Device Is Intended To Deliver Nebulized Medications Through A Ventilator Breathing Circuit.
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.