# K161530: Bluetooth blood pressure monitor

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Kingyield Technology Co., Ltd.
- Decided: Mar 31, 2017 after 302 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
BW-BW1 Bluetooth Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist using the oscillometric method, the measured data is transferred to a smart phone for the patient record archiving and/or measured data analysis purpose. The device is intended for use in only adult population, not applied to the other populations such as neonatal baby. It can not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

Source page: https://510kreport.com/device/K161530
Methodology: https://510kreport.com/methodology