# K070795: Sphygmocor Cardiovascular Management System

- Pathway: 510(k) (Traditional)
- Applicant: Atcor Medical Pty, Ltd.
- Decided: Aug 31, 2007 after 162 days
- Product code: DSK (Computer, Blood-Pressure)
- Device class: 2
- Regulation: 21 CFR 870.1110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K950779 (1995). 8 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012487: Sphygmocor PX Model Scor-PX, Atcor Medical Pty, Ltd. (2002) Summary page 1.
- K991831: BMT Anscore Health Management System, Model 1.1, Boston Medical Technologies, Inc. (1999) Summary page 1.
- K993875: BMT Anscore Health Management System, Boston Medical Technologies, Inc. (2000) Summary page 1.
- K010955: BMT Anscore Health Management System, Boston Medical Technologies, Inc. (2001) Summary page 1.
- K972991: Monitor One NDX, Qmed, Inc. (1998) Summary page 1.
- K950779: Heart Rate Variability Software Option, Spacelabs, Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K140928: ABPM7100 (2014), 5 descendants of its own
- K151520: Oscar 2 (2016), 3 descendants of its own

## Indications for use
The SphygmoCor® Cardiovascular Management System (CvMS) provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. The CvMS is used with a tonometer over a radial artery calibrated with a standard cuff blood pressure measurement. It is to be used on those patients where information related to ascending aortic blood pressure is desired but in the opinion of the physician, the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits. The CvMS heart rate variability (HRV) option is intended for use in obtaining heart rate variability measurements in response to controlled exercises.

Source page: https://510kreport.com/device/K070795
Methodology: https://510kreport.com/methodology