# K222153: Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Feb 3, 2023 after 198 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). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 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 5.
- K112845: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Microlife Intellectual Property GmbH (2011) Summary page 5.
- K013434: VP-2000/1000, Colin Corp. (2002) Summary page 5.

## Indications for use
The Microlife Upper Arm Automatic Digital Blood Pressure and Cardiovascular Screening Monitor Model WatchBP Office Vascular (TWIN200 VSR) is a non-invasive digital blood pressure device using the 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 (5.5-20.5 inches). The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia. 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 provides aortic blood pressure parameters, including central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff. This was validated against invasive blood pressure measurement and showed that the device determines central blood pressure measurement with high accuracy. The device provides a validated method for determining the ankle-brachial index (ABI) which may be useful in diagnosing Peripheral Artery Disease (PAD). The device is only intended to provide a numerical value of brachial-ankle pulse wave velocity (baPWV) for blood flow inside the intended blood vessel, without any diagnosis. The memory data can be transferred to the PC running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth. The device is intended for use by healthcare professionals in clinical practice.

Source page: https://510kreport.com/device/K222153
Methodology: https://510kreport.com/methodology