# K210152: Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Aviche Shandong Medical Technology Co, Ltd.
- Decided: Sep 23, 2021 after 245 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 K052153 (2005). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200939: Electronic Blood Pressure Monitor, Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (2020) Summary page 5.

## Indications for use
The Automatic Digital Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adult at household. (Not suitable for neonate, pregnancy or pre-eclampsia).

Source page: https://510kreport.com/device/K210152
Methodology: https://510kreport.com/methodology