# K253126: Wrist Blood Pressure Monitor (XW-05)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Ziqing Medical Equipment Co., Ltd.
- Decided: Jun 18, 2026 after 266 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: 4 generations back to K042505 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231310: Electronic Blood Pressure Monitor, Shenzhen Jumper Medical Equipment Co., Ltd. (2023) Summary page 6.

## Indications for use
This wrist blood pressure monitor is used to measure the systolic blood pressure, diastolic blood pressure and pulse rate of adults. The blood pressure monitor uses the oscillometric measurement method to inflate the cuff and pressurize it, detect the blood flow in the wrist arteries, and then convert your blood pressure into a digital reading through this device. The device is simple and convenient to use, and the patient 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/K253126
Methodology: https://510kreport.com/methodology