# K012487: Sphygmocor PX Model Scor-PX

- Pathway: 510(k) (Traditional)
- Applicant: Atcor Medical Pty, Ltd.
- Decided: Feb 21, 2002 after 203 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: 1 generation back to K002742 (2001). 1 ancestor in all.
21 later devices descend from it; 6 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002742: Sphygmocor MX Model Scor-MX, Pwv Medical Pty, Lt. (2001) Summary page 1.

## Most influential descendants
- K070795: Sphygmocor Cardiovascular Management System (2007), 16 descendants of its own
- K110603: Hypertension Management Software Claient Server (HMS-CS) (2011), 8 descendants of its own
- K080670: Modification to Sphygmocor Cardiovascular Management System (2008), 8 descendants of its own
- K122129: Sphygmocor Xcel (2012), 6 descendants of its own
- K050233: Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AI (2005), 6 descendants of its own

## Indications for use
The SphygmoCor Px provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. The SphygmoCor is used with a tonometer over the radial artery calibrated with a standard cuff blood pressure measurement. It is to be used in those patients where information related to the ascending aortic pressure is desired but in the opinion of the physician, the risks of the cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

Source page: https://510kreport.com/device/K012487
Methodology: https://510kreport.com/methodology