# K232814: Electronic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Zhuhai Yueja Medical Device Technology Co., Ltd.
- Decided: Dec 5, 2023 after 83 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: 9 generations back to K001670 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222994: Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B, Shenzhen AOJ Medical Technology Co., Ltd. (2023) Summary page 5.

## Indications for use
Electronic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm.

Source page: https://510kreport.com/device/K232814
Methodology: https://510kreport.com/methodology