# K244007: ArteVu

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Ring Technologies, Inc. Taiwan Branch
- Decided: Jul 30, 2025 after 216 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: 10 generations back to K962603 (1997). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163255: CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor, Caretaker Medical, LLC (2017) Summary page 5.

## Indications for use
ArteVu is intended to noninvasively and continuously measure a patient’s blood pressure and pulse rate, which are derived from the pulse pressure waveform using the scientific method of pulse waveform decomposition, for use on adult patients aged between 50 and 86 years who are resting in a supine or similarly reclined position. ArteVu is calibrated using an ISO 81060-2 compliant sphygmomanometer. All parameters derived by ArteVu are shown on a compatible remote display monitor (RDDS) via wired transmission. The device is intended for use by clinicians or other properly trained medical personnel in professional healthcare facilities.

Source page: https://510kreport.com/device/K244007
Methodology: https://510kreport.com/methodology