Cleared Traditional

K251275 - VitalStream ART Connect (FDA 510(k) Clearance)

Also includes:
VitalStream-Hemo

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K251275 · Caretaker Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
155d
Days
Class 2
Risk

K251275 is an FDA 510(k) clearance for the VitalStream ART Connect. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Caretaker Medical (Charlottesville, US). The FDA issued a Cleared decision on September 26, 2025 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Caretaker Medical devices

Submission Details

510(k) Number K251275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05035719 Unknown Observational Industry-sponsored

Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker Against Respective Gold Standard References

Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker

60
Patients (est.)
1
Site
Condition studied Cardiac Output, Low
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor CareTaker Medical LLC (industry)
Started 2021-03-01 → Primary completion 2022-03-31
Primary outcome
Cardiac output performance comparison
View full study on ClinicalTrials.gov