# K080337: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Corp.
- Decided: May 13, 2008 after 95 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: 3 generations back to K903134 (1991). 10 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013485: Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with Optional Thermal Printer, Model PR 1KA1, Microlife Corp. (2002) Summary page 1.
- K052767: Afibalert Atrial Fibrillation Detector, Lechnologies Research, Inc. (2006) Summary page 1.

## Most influential descendants
- K101275: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib (TWIN200 Afs). (2010), 6 descendants of its own
- 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
- K112845: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2011), 3 descendants of its own
- K200297: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2020), 2 descendants of its own

## Indications for use
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. 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/K080337
Methodology: https://510kreport.com/methodology