# K231245: Digital Blood Pressure Monitor (Arm Type)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Genial Technology Co., Ltd.
- Decided: Nov 22, 2023 after 205 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 devices are intended to measure the systolic and diastolic blood pressure, and pulse rate of an adult more than 12 years old individual by using a non-invasive technique, in which an inflatable cuff (220mm,...__, 320mm) is wrapped around the arm. It can be used in medical facilities or at home. It is supplied for OTC use.

Source page: https://510kreport.com/device/K231245
Methodology: https://510kreport.com/methodology