# K222160: GUS610 Blood pressure monitor

- Pathway: 510(k) (Traditional)
- Applicant: Globalcare Medical Technology Co., Ltd.
- Decided: Nov 22, 2022 after 125 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: 10 generations back to K001670 (2000). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192609: Globalcare Blood Pressure Monitor, Globalcare Medical Technology Co., Ltd. (2020) Summary page 7.

## Most influential descendants
- K250136: Globalcare Blood Pressure Monitor (GUS610) (2025), 0 descendants of its own

## Indications for use
The Globalcare GUS610 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/K222160
Methodology: https://510kreport.com/methodology