# K152415: Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Sunspirit Co., Ltd.
- Decided: May 6, 2016 after 254 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: 2 generations back to K042505 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083043: King`Yield Wrist Blood Pressure Monitor, Model BP201, Shenzhen Kingyield Technology Co., Ltd. (2008) Summary page 5.

## Indications for use
It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate. 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/K152415
Methodology: https://510kreport.com/methodology