VitalStream ART Connect; VitalStream Hemo; ART Dock
VitalStream ART Connect, also called VitalStream-Hemo or ART Dock, is an adapter that processes the analogue output from an invasive arterial blood pressure monitor. It supplies calibrated…
VitalStream ART Connect, also called VitalStream-Hemo or ART Dock, is an adapter that processes the analogue output from an invasive arterial blood pressure monitor. It supplies calibrated cardiac output, stroke volume and related haemodynamic parameters for adult patients in hospitals or other appropriate clinical settings.
An onboard analogue-to-digital converter digitises the raw arterial pressure signal and passes it to the Caretaker platform. Pulse Decomposition Analysis processes the signal, and the resulting parameters are provided through the Caretaker Remote Display App and software library.
Listed Item
The VitalStream ART Connect is an adapter to accept the analog output channel of commercial invasive arterial catheter blood pressure monitors. An on-board analog to digital converter provides access to a digitized version of the raw invasive blood pressure signal and presents it to the Caretaker Platform (K211588) to provide the same parameters that were previously obtained through a filtered pneumatic signal (Caretaker Advanced Hemodynamic Parameters, K213699).
Clinical Outputs
Derived measurements include cardiac index, stroke volume index, systemic vascular resistance, mean arterial pressure, heart rate and pulse pressure variation. Physicians or other appropriately trained medical personnel operate the device.
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Caretaker Medical, United States |
|---|---|
| FDA product code | DXG |
| Device type | Computer, Diagnostic, Pre-Programmed, Single-Function |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1435 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K251275 |
| Record published | 2026-06-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -25 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ART Dock | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LiDCO Ltd | Lidco Ltd. | 133 |
| LiDCO | Lidco Ltd. | 32 |
| Transonic | Transonic Systems, Inc. | 31 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | Edwards Lifesciences Technology Sarl | 23 |
| Retia Medical | Retia Medical, LLC | 17 |
| EV1000 | Edwards Lifesciences Technology Sarl | 11 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | GE Healthcare Finland OY | 5 |
| Pediasat | Edwards Lifesciences Technology Sarl | 4 |
| LiDCO | Masimo Corporation | 4 |
| ICU Medical | ICU Medical, Inc | 4 |
| Cnap® Monitor 500 HD | Cnsystems Medizintechnik GmbH | 4 |
| Vigileo | Edwards Lifesciences Technology Sarl | 3 |
Showing 12 of 39. All products under Computer, Diagnostic, Pre-Programmed, Single-Function
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251275 | 2025-09-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.