# K141083: Microlife Wrist Watch Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Aug 22, 2014 after 116 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: 6 generations back to K903134 (1991). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092456: Microlife Wrist Watch Blood Pressure Monitor, Model BP3BS1-3C, Microlife Intellectual Property GmbH (2009) Summary page 4.
- K120430: Microlife Wrist Watch Blood Preeure Monitor, BP3MO1-3P, Microlife Intellectual Property GmbH (2012) Summary page 4.

## Indications for use
The Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X 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. 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 your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.

Source page: https://510kreport.com/device/K141083
Methodology: https://510kreport.com/methodology