# K251275: VitalStream ART Connect; VitalStream-Hemo

- Pathway: 510(k) (Traditional)
- Applicant: Caretaker Medical
- Decided: Sep 26, 2025 after 155 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K023960 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181372: Argos, Retia Medical, LLC (2018) Summary page 5.

## Indications for use
The VitalStream ART Connect (aka VitalStream-Hemo) provides calibrated cardiac output/stroke volume (CO) and derived parameters, including cardiac index (Cl), stroke volume (SV), stroke volume index (SVI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), mean arterial pressure (MAP), heart rate (HR), and pulse pressure variation (PPV) in adult patients to the existing Caretaker Remote Display App And Caretaker Software Library (K181196) via Pulse Decomposition Analysis ("PDA") (K211588, K163255, K151499). The device is intended for use on adult patients by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.

Source page: https://510kreport.com/device/K251275
Methodology: https://510kreport.com/methodology