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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K250345
Device Name Medline Bag Decanter
Applicant
Medline Industries, LP
Three Lakes Dr.
Northfiled,  IL  60093
Applicant Contact Susan Moynihan
Correspondent
Medline Industries, LP
Three Lakes Dr.
Northfiled,  IL  60093
Correspondent Contact Susan Carlson
Regulation Number880.5440
Classification Product Code
LHI  
Date Received02/06/2025
Decision Date 10/24/2025
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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