Medical Mesh Nebulizer (AirICU Max+)— 510(k) K251584

Name: FDA 510(k) clearance K251584
Creator: U.S. Food and Drug Administration
Published: 2026-03-12

Substantially Equivalent

AIRICU, Inc.

FDA 510(k) clearance K251584 for Medical Mesh Nebulizer (AirICU Max+), Substantially Equivalent on 2026-03-12. Applicant: AIRICU, Inc.. Device class: 2.

Clearance details

Applicant: AIRICU, Inc.
Product code: Code SFP
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 2025-05-23
Decision date: 2026-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: City Of Industry, CA, US

Download summary PDF View on FDA.gov ↗

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