# K162089: Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Choice Electronic Technology Co., Ltd.
- Decided: Feb 10, 2017 after 197 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 K001670 (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)
- K143735: Digital Automatic Blood Pressure Monitor MD2300, Grandway Technology (Shenzhen) Limited (2015) Summary page 4.

## Indications for use
The Blood Pressure Monitor CBP111/CBP112 is intended for non-invasive measuring of an adult individual’s systolic, diastolic blood pressure and heart rate in hospital, at home or clinical use. Blood pressure readings should be taken on the upper arm of an adult only, and the suitable cuff size is from 22cm to 32cm.

Source page: https://510kreport.com/device/K162089
Methodology: https://510kreport.com/methodology