# K112845: Microlife Upper Arm Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Dec 5, 2011 after 67 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). 25 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082357: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office (TWIN200)., Microlife Intellectual Property GmbH (2008) Summary page 1.
- K080337: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D, Microlife Corp. (2008) Summary page 1.
- K013434: VP-2000/1000, Colin Corp. (2002) Summary page 1.

## Most influential descendants
- K171937: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2018), 1 descendant of its own
- K253306: BioTracker 2.0 (2026), 0 descendants of its own
- K222153: Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) (2023), 0 descendants of its own

## Indications for use
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AD! (TWIN200 ABI) is a device intended to measure the systolic and diastolic blood pressure, pulse rate and calculate Pulse Pressure (PP), Mean Arterial Pressure (MAP) and Ankle Brachial Index (ABI) of an adult individual by using a non-invasive oscillomnetric technique in one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s) and one inflatable cuff is wrapped around the ankle. 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 device can be used in connection with your personal computer (PC) running the WatchBP Analyzer Office ABI software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.

Source page: https://510kreport.com/device/K112845
Methodology: https://510kreport.com/methodology