# K151330: Microlife Wrist Watch Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH, Switzerland
- Decided: Jul 14, 2015 after 56 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). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120430: Microlife Wrist Watch Blood Preeure Monitor, BP3MO1-3P, Microlife Intellectual Property GmbH (2012) Summary page 4.
- K040002: Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1, Microlife Intellectual Property Gmb (2004) Summary page 4.

## Most influential descendants
- K211288: Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B (2021), 1 descendant of its own
- 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 BP3NN1-3E 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/K151330
Methodology: https://510kreport.com/methodology