# K180435: Arm Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Alicn Medical (Shenzhen), Inc.
- Decided: Jan 3, 2019 after 317 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: 2 generations back to K001670 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160019: U80 Series Upper Arm Electronic Blood Pressure Monitor, Shenzhen Urion Technology Co., Ltd. (2016) Summary page 5.

## Indications for use
The Arm 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 upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-32cm.Suitable for adults who over the age of 12.

Source page: https://510kreport.com/device/K180435
Methodology: https://510kreport.com/methodology