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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K251275
Device Name VitalStream ART Connect; VitalStream-Hemo
Applicant
Caretaker Medical
941 Glenwood Station Ln.
Suit 301
Charlottesville,  VA  22901
Applicant Contact Jeff Pompeo
Correspondent
Caretaker Medical
941 Glenwood Station Ln.
Suit 301
Charlottesville,  VA  22901
Correspondent Contact Jeff Pompeo
Regulation Number870.1435
Classification Product Code
DXG  
Date Received04/24/2025
Decision Date 09/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT05035719
NCT05905536
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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