# K073630: Modification to: Bpcard, Model Z-7000-0700

- Pathway: 510(k) (Special)
- Applicant: Qrs Diagnostic, LLC
- Decided: Jan 11, 2008 after 16 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: 2 generations back to K913844 (1992). 2 ancestors in all.
2 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)
- K031964: Bpcard, Qrs Diagnostic, LLC (2003) Summary page 1.

## Most influential descendants
- 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, adult subjects. The BPCard also measures heart rate. * Patient Population: Male/Female, Adults * Environment of Use: Hospital, Clinic and Home Use * Prescription Device by a Physician

Source page: https://510kreport.com/device/K073630
Methodology: https://510kreport.com/methodology