# K193348: Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Viatom Technology Co., Ltd.
- Decided: Jun 25, 2020 after 205 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: 7 generations back to K963725 (1997). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182579: Omron Model BP7900 Blood Pressure Monitor + EKG, Omron Healthcare, Inc. (2019) Summary page 5.

## Indications for use
The Blood Pressure Monitor is indented to measure blood pressure or electrocardiogram (ECG) in home or healthcare facilities environment. The device is a blood pressure monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to measure, display, store and review adults’ single-channel ECG rhythms and gives some suggested symptoms such as regular beat, irregular beat, low HR and high HR. The ECG part of the device is for Rx only, and the blood pressure part is for OTC.

Source page: https://510kreport.com/device/K193348
Methodology: https://510kreport.com/methodology