# K101275: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib (TWIN200 Afs).

- Pathway: 510(k) (Special)
- Applicant: Microlife Intellectual Property GmbH
- Decided: May 28, 2010 after 22 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.
6 later devices descend from it; 2 cite it directly.
0 of 32 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.

## Most influential descendants
- K143341: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2015), 4 descendants of its own
- K152770: ProBP 2400 Digital Blood Pressure Device (2015), 3 descendants of its own
- K200297: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2020), 2 descendants of its own
- 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 AFIB (TWIN200 AFS) is a device intended to measure the systolic and diastolic blood pressure, pulse rate, pulse pressure (PP) and mean arterial pressure (MAP) of an adult individual by using a non-invasive oscillometric technique in one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s). The device detects the appearance of.atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.

Source page: https://510kreport.com/device/K101275
Methodology: https://510kreport.com/methodology
