Cleared Traditional

Medical Mesh Nebulizer (AirICU Max+)

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

About This 510(k) Submission

K251584 is an FDA 510(k) clearance for the Medical Mesh Nebulizer (AirICU Max+), a Ventilator-compatible Nebulizer (Class II — Special Controls, product code SFP), submitted by AIRICU, Inc. (City Of Industry, US). The FDA issued a Cleared decision on March 12, 2026, 293 days after receiving the submission on May 23, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K251584 FDA.gov
FDA Decision Cleared 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

Device Classification

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