# K211588: Caretaker Platform, VitalStream Platform, CT5

- Pathway: 510(k) (Special)
- Applicant: Caretaker Medical
- Decided: Aug 13, 2021 after 81 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962603 (1997). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151499: CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor, Caretaker Medical, LLC (2016) Summary page 4.
- K163255: CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor, Caretaker Medical, LLC (2017) Summary page 4.
- K181196: Caretaker Remote Display App and Caretaker Software Library, Caretaker Medical, LLC (2018) Summary page 4.

## Indications for use
The Caretaker Platform is intended for non-invasive, continuous or spot-check measurement of hemodynamic parameters. Parameters can be reported to an integrated screen and optionally to Remote Data Display Systems (RDDS) and/or the Caretaker Remote Monitor App via standard wireless or wired data transmission protocols. The device is intended for use by clinicians or other properly trained personnel on adult patients at rest.

Source page: https://510kreport.com/device/K211588
Methodology: https://510kreport.com/methodology