# K053395: BP Pro Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Dec 23, 2005 after 17 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 K021682 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041313: Stabil-O-Graph, I.E.M. GmbH (2004) Summary page 1.

## Most influential descendants
- K060703: PMP4 BP Pro Blood Pressure Monitor (2006), 0 descendants of its own

## Indications for use
BP Pro is intended to be used by adults at home to monitor Blood Pressure (systolic and diastolic) and pulse rate from the upper arm with arm circumference ranging from 9.4 inches to 16.5 inches (24 cm to 42 cm).

Source page: https://510kreport.com/device/K053395
Methodology: https://510kreport.com/methodology