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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 K251615
Device Name Aerogen Pro-X1 Controller System
Applicant
Aerogen, Ltd.
Galway Business Park
Dangan
Galway,  IE H91 HE94
Applicant Contact Thelma Marley
Correspondent
Aerogen, Ltd.
Galway Business Park
Dangan
Galway,  IE H91 HE94
Correspondent Contact Thelma Marley
Regulation Number868.5630
Classification Product Code
SFP  
Date Received05/27/2025
Decision Date 09/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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