# K192609: Globalcare Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Globalcare Medical Technology Co., Ltd.
- Decided: Apr 21, 2020 after 214 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: 9 generations back to K001670 (2000). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141984: Fully Automatic Electronic Blood Pressure Monitor, Andon Health Co, Ltd. (2015) Summary page 6.

## Most influential descendants
- K222160: GUS610 Blood pressure monitor (2022), 1 descendant of its own
- K250136: Globalcare Blood Pressure Monitor (GUS610) (2025), 0 descendants of its own
- K231303: Arm-type Fully Automatic Digital Blood Pressure Monitor (2024), 0 descendants of its own

## Indications for use
The Globalcare GUS622 automatic Blood Pressure Monitor is indicated for home use for the non-invasive measurement of diastolic and systolic blood pressures and pulse rate of adults by means of an inflatable cuff which is wrapped around the upper arm. The cuff circumference is limited to 22 to 42 cm.

Source page: https://510kreport.com/device/K192609
Methodology: https://510kreport.com/methodology