# K191894: Upper Arm Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Zhengkang Technology Co., Ltd.
- Decided: Feb 21, 2020 after 221 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K172171: Digital Blood Pressure Monitor Models: B01, B02, B05 & B06T. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4.

## Most influential descendants
- K250185: Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) (2025), 0 descendants of its own
- K221040: Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) (2022), 0 descendants of its own

## Indications for use
This Upper Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home.

Source page: https://510kreport.com/device/K191894
Methodology: https://510kreport.com/methodology