# K191593: Digital Automatic Blood Pressure Monitor MD36 Series

- Pathway: 510(k) (Special)
- Applicant: Grandway Technology (Shenzhen) Limited
- Decided: Jul 22, 2019 after 38 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: 6 generations back to K001670 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163679: Digital Automatic Blood Pressure Monitor MD3600, Grandway Technology (Shenzhen) Limited (2017) Summary page 4.

## Indications for use
The upper arm blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken.

Source page: https://510kreport.com/device/K191593
Methodology: https://510kreport.com/methodology