# K153077: Microlife Upper Arm Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Feb 12, 2016 after 112 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). 21 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140572: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Microlife Intellectual Property GmbH, Switzerland (2014) Summary page 4.
- K151869: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Microlife Intellectual Property GmbH, Switzerland (2015) Summary page 4.

## Most influential descendants
- K222979: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W (2023), 5 descendants of its own
- K232621: Blood pressure monitor (2023), 3 descendants of its own
- K172498: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y (2017), 3 descendants of its own
- K230075: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K (2023), 2 descendants of its own
- K251120: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) (2025), 1 descendant of its own

## Indications for use
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW 1-4B is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual by using a non-invasive oscillometric technique in one inflatable cuff is wrapped around the single upper arm. The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. This device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia. The memory data can be transferred to the PC (personal computer) running the Microlife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth. The blood pressure monitor is a fully automatic digital blood pressure measuring device for use by adults on the upper arm at home.

Source page: https://510kreport.com/device/K153077
Methodology: https://510kreport.com/methodology