# K253228: YUWELL® Electronic Blood Pressure Monitor (YE650AR)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Decided: Feb 23, 2026 after 147 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200939: Electronic Blood Pressure Monitor, Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (2020) Summary page 5.

## Indications for use
This product is indicated for measuring blood pressure and pulse rate in patients older than 12 years. 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/K253228
Methodology: https://510kreport.com/methodology