# K221372: YUWELL Electronic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Decided: Oct 17, 2022 after 158 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). 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)
- K182166: Wrist Blood Pressure Monitor Model BP4350, Omron Healthcare, Inc. (2018) Summary page 4.

## Indications for use
This product is intended to measure the blood pressure and pulse rate of adult more than 12 years old and with wrist circumference ranging from 13.5 cm to 19.5 cm at household or medical center (not suitable for neonate, pregnancy or pre-eclampsia.)

Source page: https://510kreport.com/device/K221372
Methodology: https://510kreport.com/methodology