Cleared Traditional

VitalStream ART Connect; VitalStream-Hemo

K251275 · Caretaker Medical · Cardiovascular

Sep 2025

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K251275 is an FDA 510(k) clearance for the VitalStream ART Connect; VitalStream-Hemo, a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Caretaker Medical (Charlottesville, US). The FDA issued a Cleared decision on September 26, 2025, 155 days after receiving the submission on April 24, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number	K251275 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2025
Decision Date	September 26, 2025
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF