# K190207: Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Viatom Technology Co., Ltd.
- Decided: Aug 19, 2019 after 196 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 K052676 (2006). 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)
- K080326: KD-391 Semi Automatic Electronic Blood Pressure Monitor, Andon Health Co, Ltd. (2008) Summary page 5.

## Indications for use
The subject device intended to measure the diastolic, systolic blood pressures and pulse rate for adult population in home and hospital facilities by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The device detects the appearance of irregular heart beats during measurement and gives a warning signal with readings.

Source page: https://510kreport.com/device/K190207
Methodology: https://510kreport.com/methodology