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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K250325
Device Name BD Alaris Pump Infusion Set
Applicant
Carefusion (Bd)
10200 Pacific Mesa Blvd.
San Diego,  CA  92121
Applicant Contact Amy Honey
Correspondent
Carefusion (Bd)
10200 Pacific Mesa Blvd.
San Diego,  CA  92121
Correspondent Contact Michael Pacelli
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/05/2025
Decision Date 10/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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