# K153033: Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Sunspiri Co., Ltd.
- Decided: Jun 24, 2016 after 249 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: 3 generations back to K052153 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130325: Arm Automatic Blood Pressure Monitor, Shenzhen Pump Medical System Co., Ltd. (2013) Summary page 5.

## Indications for use
This device is intended to measure the blood pressure and pulse rate on upper arms of adults.

Source page: https://510kreport.com/device/K153033
Methodology: https://510kreport.com/methodology