# K080670: Modification to Sphygmocor Cardiovascular Management System

- Pathway: 510(k) (Special)
- Applicant: Atcor Medical
- Decided: Apr 23, 2008 after 44 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: 5 generations back to K950779 (1995). 18 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 27 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 1.
- K013434: VP-2000/1000, Colin Corp. (2002) Summary page 1.

## Most influential descendants
- K122129: Sphygmocor Xcel (2012), 6 descendants of its own
- 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

## 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 HRV measurements in response to controlled exercises. The CvMS Pulse Wave Velocity (PWV) option is intended for use in obtaining PWV measurements. The PWV option is used on adult patients only.

Source page: https://510kreport.com/device/K080670
Methodology: https://510kreport.com/methodology