# K190982: Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Xiamen Ants Bro Technology Co., Ltd.
- Decided: May 29, 2020 after 410 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: 11 generations back to K001670 (2000). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171833: Digital Blood Pressure Monitor-Wrist Style, Shenzhen Combei Technology Co., Ltd. (2018) Summary page 5.
- K153552: AGE Automatic Upper Arm Blood Pressure Monitor, Ageless Health Industrial Co., Ltd. (2016) Summary page 5.

## Indications for use
Automatic Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm. It can be used at medical facilities or at home. The intended wrist circumference is 12.5~20 cm and the intended arm circumference has several models: 23~33 cm, 25~35 cm, 22~42 cm, 33~43 cm .

Source page: https://510kreport.com/device/K190982
Methodology: https://510kreport.com/methodology