# K261082: Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Corporation
- Decided: Jul 23, 2026 after 113 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: 8 generations back to K903134 (1991). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211288: Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B, Microlife Intellectual Property GmbH (2021) Summary page 5.

## Indications for use
The Microlife Wrist Blood Pressure Monitor Model, BPHJG5-G is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm. The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.

Source page: https://510kreport.com/device/K261082
Methodology: https://510kreport.com/methodology