# K041693: Wrist Digital Blood Pressure Monitor (Digital Sphygmomanometer), MW-300 Series

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,
- Decided: Dec 2, 2004 after 163 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
The model MW-300 series wrist pressure monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.

Source page: https://510kreport.com/device/K041693
Methodology: https://510kreport.com/methodology