# K221040: Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Aicare Medical Technology Co., Ltd.
- Decided: Aug 31, 2022 after 146 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: 1 generation back to K191894 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191894: Upper Arm Blood Pressure Monitor, Shenzhen Zhengkang Technology Co., Ltd. (2020) Summary page 4.

## Indications for use
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.

Source page: https://510kreport.com/device/K221040
Methodology: https://510kreport.com/methodology