# K252779: YUWELL® Electronic Blood Pressure Monitor (YE630CR)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Decided: Mar 5, 2026 after 184 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 K052153 (2005). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162092: Evolv Model BP7000 Upper Arm Blood Pressure Monitor, Omron Healthcare, Inc. (2016) Summary page 5.

## Indications for use
This device is intended to measure blood pressure and pulse rate in patients over 12 years old with an upper-arm circumference ranging from 22 cm to 45 cm (8.7 in to 17.7 in). It is not suitable for neonates, pregnant individuals, or patients with pre-eclampsia. The device can be used at home or in a healthcare facility.

Source page: https://510kreport.com/device/K252779
Methodology: https://510kreport.com/methodology