# K111652: Microlife Automatic Talking Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Jul 13, 2011 after 30 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: 5 generations back to K903134 (1991). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061471: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC, Microlife Intellectual Property GmbH (2006) Summary page 1.
- K041778: Reizen Talking Blood Pressure Monitor, Model #SF860T, Maxi-Aids, Inc. (2004) Summary page 1.

## Most influential descendants
- K131346: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2013), 3 descendants of its own
- K172880: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2018), 2 descendants of its own
- K183469: Microlife Digital Blood Pressure Monitor (2019), 1 descendant of its own
- K190818: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2019), 0 descendants of its own

## Indications for use
The Automatic Talking Blood Pressure Monitor, Model BP3AP1-3E (BP A130) 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 irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.

Source page: https://510kreport.com/device/K111652
Methodology: https://510kreport.com/methodology