# K032825: Vital Vision Arterial Hardness and Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mars Medical Products Co., Ltd.
- Decided: Dec 10, 2004 after 457 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
1. The device is designed to provide signals from which systolic, diastolic pressures and H-Value (arterial stiffness index) can be derived through the use of the Oscillometric method. The device also measure pulse rate. 2. Adult Use Only 3. For use in the clinical setting or home use under the direction of a physician.

Source page: https://510kreport.com/device/K032825
Methodology: https://510kreport.com/methodology