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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator-Compatible Nebulizer
510(k) Number K251584
Device Name Medical Mesh Nebulizer (AirICU Max+)
Applicant
AIRICU, Inc.
220 N California Suite A
City Of Industry,  CA  91744
Applicant Contact Jay Li
Correspondent
AIRICU, Inc.
220 N California Suite A
City Of Industry,  CA  91744
Correspondent Contact Jay Li
Regulation Number868.5630
Classification Product Code
SFP  
Date Received05/23/2025
Decision Date 03/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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