# K143341: Microlife Upper Arm Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Apr 21, 2015 after 151 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). 29 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K101275: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib (TWIN200 Afs)., Microlife Intellectual Property GmbH (2010) Summary page 4.
- K140572: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Microlife Intellectual Property GmbH, Switzerland (2014) Summary page 4.

## Most influential descendants
- K152770: ProBP 2400 Digital Blood Pressure Device (2015), 3 descendants of its own
- K200297: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2020), 2 descendants of its own
- K222153: Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) (2023), 0 descendants of its own
- K202729: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2021), 0 descendants of its own

## Indications for use
The ProBP 2400 is a non-invasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate and mean arterial pressure (MAP). 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 accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.

Source page: https://510kreport.com/device/K143341
Methodology: https://510kreport.com/methodology