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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K252636
Device Name Fluido Compact System
Applicant
The Surgical Company International B.V.
Paalbergweg 3
Amsterdam,  NL 1105 AG
Applicant Contact Gianpaolo Soares
Correspondent
The Surgical Company International B.V.
Paalbergweg 3
Amsterdam,  NL 1105 AG
Correspondent Contact Gianpaolo Soares
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received08/20/2025
Decision Date 11/18/2025
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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