# K031964: Bpcard

- Pathway: 510(k) (Traditional)
- Applicant: Qrs Diagnostic, LLC
- Decided: Sep 5, 2003 after 72 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 K913844 (1992). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913844: Accutracker DX, Suntech Medical Instruments, Inc. (1992) Summary page 2.

## Most influential descendants
- K073630: Modification to: Bpcard, Model Z-7000-0700 (2008), 2 descendants of its own
- K103703: Reguis Sigma (2011), 1 descendant of its own
- K120131: Regius SIGMA2 (2012), 0 descendants of its own

## Indications for use
The BPCard is a non-invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method in both male and female, pediatric and adult subjects. The BPCard also measures heart rate. It is to be used by health care professionals in a hospital, clinic or home environment. It is contraindicated in-patients who are not ambulatory, have heart failure, arrhythmia, or cardiac valve abnormality. It is not to be operated in an explosive atmosphere nor in proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the BPCard.

Source page: https://510kreport.com/device/K031964
Methodology: https://510kreport.com/methodology