# K232815: Wrist Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Zhuhai Yueja Medical Device Technology Co., Ltd.
- Decided: Dec 11, 2023 after 89 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: 7 generations back to K001671 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223291: Electronic Blood Pressure Monitor, Shenzhen Pango Medical Electronics Co., Ltd. (2023) Summary page 5.

## Indications for use
Wrist Blood Pressure Monitor is used to measure adult systolic blood pressure. diastolic blood pressure and pulse rate. The values are for diagnostic reference only. Suitable for medical institutions (such as hospitals, clinics, health centers, etc.) and home use.

Source page: https://510kreport.com/device/K232815
Methodology: https://510kreport.com/methodology