# K181104: Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Combei Technology Co., Ltd.
- Decided: Aug 29, 2018 after 125 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 K903134 (1991). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091434: Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M, Truly Instrument Co., Ltd. (2009) Summary page 5.

## Most influential descendants
- K181894: TOF-Cuff monitor (2019), 0 descendants of its own

## 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 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. The Subject device is not intended to be diagnostic device.

Source page: https://510kreport.com/device/K181104
Methodology: https://510kreport.com/methodology