# K200297: Microlife Upper Arm Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Jun 18, 2020 after 133 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: 10 generations back to K903134 (1991). 31 ancestors in all.
2 later devices descend from it; 2 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)
- K152770: ProBP 2400 Digital Blood Pressure Device, Microlife Intellectual Property GmbH (2015) Summary page 4.

## Most influential descendants
- 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 Microlife Upper Arm Automatic Digital Blood Pressure Monitor,Model WatchBP Office (BP3SK1-3B) 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, mean arterial pressure (MAP) for use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm. The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia. The device provides aortic blood pressure parameters, includes central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood 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 memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth. The device is for hospital use only.

Source page: https://510kreport.com/device/K200297
Methodology: https://510kreport.com/methodology