# K231542: Digital Blood Pressure Monitor WBP Series

- Pathway: 510(k) (Traditional)
- Applicant: Weony (Shenzhen) Technology Co., Ltd.
- Decided: Sep 7, 2023 after 100 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 K903134 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131742: HEM-6131, Omron Healthcare, Inc. (2013) Summary page 5.
- K210671: Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107, Weony (Shenzhen) Technology Co., Ltd. (2021) Summary page 5.

## Indications for use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 13.5cm to 21.5cm in home and hospital facilities by using a non-invasive oscillometric technique. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Source page: https://510kreport.com/device/K231542
Methodology: https://510kreport.com/methodology