# K163606: Digital Blood Pressure Monitor-Automatic Upper Arm Style

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Combei Technology Co., Ltd.
- Decided: May 9, 2017 after 139 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: 10 generations back to K001670 (2000). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150430: Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor, Fudakang Industrial Co., Ltd. (2015) Summary page 5.

## Indications for use
The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff (size: 22~32cm(8.7~12.6in) is wrapped around the single upper arm. The Subject device is not intended to be diagnostic device.

Source page: https://510kreport.com/device/K163606
Methodology: https://510kreport.com/methodology