# K200649: Arm-Type Fully Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Joytech Healthcare Co., Ltd.
- Decided: Aug 3, 2020 after 144 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: 6 generations back to K061822 (2006). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K161886: Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device, Guangdong Transtek Medical Electronics Co., Ltd. (2016) Summary page 4.

## Indications for use
The Fully Automatic Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.

Source page: https://510kreport.com/device/K200649
Methodology: https://510kreport.com/methodology