# K222394: Electronic Sphygmomanometers

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Yasee Medical Device Co., Ltd.
- Decided: Mar 3, 2023 after 207 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)
- K150908: XM-01 Electronic Automatic Blood Pressure Monitor, Sky Innovation Technology ( Shanghai) Limited (2015) Summary page 4.

## Indications for use
Electronic Sphygmomanometer (Model JN-163EW) is a home use digital monitor intended for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.5 cm to 19.5 cm. The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Source page: https://510kreport.com/device/K222394
Methodology: https://510kreport.com/methodology