# K213699: CareTaker Monitor App

- Pathway: 510(k) (Traditional)
- Applicant: Caretaker Medical, LLC
- Decided: Mar 30, 2022 after 127 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: 5 generations back to K963725 (1997). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072049: Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time Hemodynamics, Bmeye B.V. (2007) Summary page 4.
- K023338: Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2, Fms, Finapres Medical Systems BV (2003) Summary page 4.
- K123130: Answatch Wrist Monitor Model TS-0411, Taiwan Scientific Corporation (2013) Summary page 4.

## Indications for use
The Caretaker Advanced Hemodynamic Parameters provides calibrated cardiac output/stroke volume (CO/SV), left ventricular ejection time (LVET), and heart rate variability (HRV) in adult patients to the existing Caretaker Remote Display App And Caretaker Software Library (K181196) via Pulse Decomposition Analysis ("PDA")(K211588, K163255, K151499). To provide CO/SV measurements, the Caretaker platform is to be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure accuracy. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.

Source page: https://510kreport.com/device/K213699
Methodology: https://510kreport.com/methodology