# K211288: Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Nov 4, 2021 after 190 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: 7 generations back to K903134 (1991). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151330: Microlife Wrist Watch Blood Pressure Monitor, Microlife Intellectual Property GmbH, Switzerland (2015) Summary page 4.
- K182166: Wrist Blood Pressure Monitor Model BP4350, Omron Healthcare, Inc. (2018) Summary page 4.

## Most influential descendants
- K261082: Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) (2026), 0 descendants of its own

## Indications for use
The Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B 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. The device can be used in connection with a smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.

Source page: https://510kreport.com/device/K211288
Methodology: https://510kreport.com/methodology