# K202729: Microlife Upper Arm Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Apr 8, 2021 after 202 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: 11 generations back to K903134 (1991). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200297: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Microlife Intellectual Property GmbH (2020) Summary page 4.
- K082881: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp O3, Microlife Intellectual Property GmbH (2008) Summary page 4.

## Indications for use
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor,Model WatchBP 03 (BP3SZl-1) is a non-invasive 24 hour ambulatory blood pressure monitor (ABPM) using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for or 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 intended to be used by healthcare professionals and patients in clinical and patient's environments.

Source page: https://510kreport.com/device/K202729
Methodology: https://510kreport.com/methodology