# K253124: Upper arm electronic blood pressure monitor (XB-01)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Ziqing Medical Equipment Co., Ltd.
- Decided: Jun 3, 2026 after 251 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: 5 generations back to K052153 (2005). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240832: Blood Pressure Monitor (BBZ32-AA01), Guangdong Transtek Medical Electronics Co., Ltd. (2024) Summary page 6.
- K200939: Electronic Blood Pressure Monitor, Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (2020) Summary page 10.

## Indications for use
This upper arm electronic blood pressure monitor is used to measure the systolic blood pressure, diastolic blood pressure and pulse rate of adults. The electronic blood pressure monitor adopts the oscillographic measurement method, inflates the cuff, detects the blood flow of the brachial artery in the upper arm, and then converts your blood pressure into a digital reading through the device. The device is simple and convenient to use, and patients can complete the measurement by themselves. This device is suitable for non-invasive monitoring of blood pressure and pulse rate in adults (18 years and above), and is limited to auxiliary measurements in home and medical environments, and cannot be used as the sole basis for clinical diagnosis.

Source page: https://510kreport.com/device/K253124
Methodology: https://510kreport.com/methodology