# K143734: Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810

- Pathway: 510(k) (Traditional)
- Applicant: Grandway Technology (Shenzhen) Limited
- Decided: May 2, 2015 after 123 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: 4 generations back to K001670 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133619: Digital Automatic Blood Pressure Monitor BPM18 Series, Grandway Technology (Shenzhen) Limited (2014) Summary page 4.

## Indications for use
The upper arm blood pressure monitor is used for non-invasive measurement and monitoring of adults’ arterial blood pressure. You can use it to measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the upper arm. Quickly and easily, storing the results and displaying the progression of readings together with the average.

Source page: https://510kreport.com/device/K143734
Methodology: https://510kreport.com/methodology