# K200738: Microlife Upper Arm Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Jul 23, 2020 after 122 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100763: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watch BP Home N BP3MX1-4, Microlife Intellectual Property GmbH (2010) Summary page 4.

## Indications for use
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual with arm cuff circumference sizes ranging from 22 -42 cm by using a non-invasive oscillometric technique in one inflatable cuff being wrapped around the upper arm. The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected. The memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer Home 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 device is intended for use by patient at home or by health care givers in primary care settings.

Source page: https://510kreport.com/device/K200738
Methodology: https://510kreport.com/methodology