# K213189: Wrist-type Fully Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Joytech Healthcare Co., Ltd.
- Decided: Mar 1, 2022 after 153 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 K173024 (2018). 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)
- K173024: Non-invasive blood pressure measurement systems, Joytech Healthcare Co., Ltd. (2018) Summary page 4.

## Indications for use
The Wrist-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age.

Source page: https://510kreport.com/device/K213189
Methodology: https://510kreport.com/methodology