# K122129: Sphygmocor Xcel

- Pathway: 510(k) (Traditional)
- Applicant: Atcor Medical
- Decided: Nov 16, 2012 after 121 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: 7 generations back to K903134 (1991). 30 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070795: Sphygmocor Cardiovascular Management System, Atcor Medical Pty, Ltd. (2007) Summary page 2.
- K080670: Modification to Sphygmocor Cardiovascular Management System, Atcor Medical (2008) Summary page 2.
- K083093: Cheetah Reliant, Cheetah Medical, Inc. (2008) Summary page 3.

## Most influential descendants
- K151520: Oscar 2 (2016), 3 descendants of its own
- K210139: Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 (2021), 1 descendant of its own
- K251581: Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (2026), 0 descendants of its own
- K251591: Holter ECG and ABP system (HolterABP) (2026), 0 descendants of its own
- K221742: Conneqt Pulse (2023), 0 descendants of its own

## Indications for use
The SphygmoCore XCEL System provides a derived ascending aortic blond pressure waveform and range of central arterial indices. These measurements are provided non-invasively through the use of a Brachial cuff. It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits. Additionally, the SphygmoCoro XCEL System automatically measures Systolic blood pressure and Diastolic blood pressure. The SphygmoCore XCEL Pulse Wave Velocity (PWV) option is intended to obtain PWV measurements. The PWV option is used on adult patients only.

Source page: https://510kreport.com/device/K122129
Methodology: https://510kreport.com/methodology