# K171937: Microlife Upper Arm Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Mar 16, 2018 after 261 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). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112845: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Microlife Intellectual Property GmbH (2011) Summary page 4.

## Most influential descendants
- K253306: BioTracker 2.0 (2026), 0 descendants of its own

## Indications for use
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office Central (TWIN200 CBP) is a device intended to measure the systolic and diastolic blood pressure, pulse rate, Mean Arterial Pressure (MAP), ankle-arm blood pressure and calculates Pulse Pressure (PP) and Ankle Brachial Index (ABI) of an adult individual with arm circumference sizes ranging from 22-42 cm and ankle circumference sizes ranging from 22-32 cm. It uses a non-invasive oscillometric technique using one (single arm) or two (dual arm measurement) inflatable cuffs wrapped around the upper arms and one inflatable cuff wrapped around the ankle (ABI). The device provides aortic blood pressure parameters, includes central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic pressure (cDBP), non-invasively through the use of a brachial cuff. The device detects the appearance of atrial fibrillation during measurement and gives a warning signal together with the measured blood pressure value if atrial fibrillation is detected. The device can be connected to a personal computer (PC) running the WatchBP Analyzer Office software. The measured patient data can be transferred from the blood pressure monitor to the PC by means of a USB cable connection. The blood pressure monitor is an automated digital professional clinical device for measuring blood pressure in upper arm and ankle in adults. The device is for hospital use only.

Source page: https://510kreport.com/device/K171937
Methodology: https://510kreport.com/methodology