# K250136: Globalcare Blood Pressure Monitor (GUS610)

- Pathway: 510(k) (Special)
- Applicant: Globalcare Medical Technology Co., Ltd.
- Decided: Apr 8, 2025 after 81 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: 11 generations back to K001670 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222160: GUS610 Blood pressure monitor, Globalcare Medical Technology Co., Ltd. (2022) Summary page 5.

## 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 52 cm.

Source page: https://510kreport.com/device/K250136
Methodology: https://510kreport.com/methodology