# K140583: Digital Automatic Blood Pressure Monitor BPM20 Series

- Pathway: 510(k) (Traditional)
- Applicant: Grandway Technology (Shenzhen) Limited
- Decided: Jun 18, 2014 after 104 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: 3 generations back to K982481 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072137: Avita Bluetooth Blood Pressure Monitor, Model: BPM656ZB, Avita Corporation (2007) Summary page 2.

## Indications for use
Digital Automatic Blood Pressure Monitor BPM20 Series is for use by medical professional or home user. The BPM20 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm of an individual. The inflatable cuff circumference is limited to 17cm - 44cm via 3 different size of cuffs. The 3 different cuff sizes are 17 - 22cm, 22 - 32cm and 32 - 44cm. For Bluetooth capable models, the measurement result can be transmitted to pre-approved mobile devices.

Source page: https://510kreport.com/device/K140583
Methodology: https://510kreport.com/methodology