# K092514: Upperarm Digital Blood Pressure Monitor, Model: MB-300 Series

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,
- Decided: Dec 4, 2009 after 109 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 MB-300 Series Upperarm Digital Blood Pressure Monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in home use setting. Use is intended by the individual or as part of a hypertension diagnosis and management program supervised by a health care provider.

Source page: https://510kreport.com/device/K092514
Methodology: https://510kreport.com/methodology