# K162616: Wrist Type Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Xuzhou Yongkang Electronic Science Technology Co., Ltd.
- Decided: Mar 9, 2018 after 535 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: 5 generations back to K001671 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131569: PG-800A Series, Shenzhen Pango Electronic Co., Ltd. (2013) Summary page 6.

## Indications for use
The Wrist Type Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the Wrist. It can be used at medical facilities or at home. The cuff size is 310 mm x 75 mm, and the intended wrist circumference is 13.5 - 19.5 cm.

Source page: https://510kreport.com/device/K162616
Methodology: https://510kreport.com/methodology