# K221742: Conneqt Pulse

- Pathway: 510(k) (Traditional)
- Applicant: Atcor Medical
- Decided: Apr 21, 2023 after 310 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 K001670 (2000). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122129: Sphygmocor Xcel, Atcor Medical (2012) Summary page 4.
- K162144: iHealth Wireless Blood Pressure Monitor, Andon Health Co, Ltd. (2017) Summary page 4.

## Indications for use
CONNEQT PULSE is a non-invasive blood pressure measurement system that provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively using a technique in which an inflatable cuff is wrapped around the upper arm. Additionally, the CONNEQT PULSE automatically provides brachial systolic and diastolic blood pressures and heart rate. The measurement range of the cuff circumference is 8.6’’-12.6’’(22cm-32cm) and 12.6’’- 16.5’’(32cm-42cm).

Source page: https://510kreport.com/device/K221742
Methodology: https://510kreport.com/methodology