# K061403: Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U

- Pathway: 510(k) (Special)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Jun 14, 2006 after 26 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: 2 generations back to K021305 (2002). 2 ancestors in all.
20 later devices descend from it; 1 cites 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)
- K040002: Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1, Microlife Intellectual Property Gmb (2004) Summary page 1.

## Most influential descendants
- K080177: Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV (2008), 19 descendants of its own
- K092161: Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BF (2009), 14 descendants of its own
- K093831: Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RT (2010), 12 descendants of its own
- K131121: Full Automatic (Nibp) Blood Pressure Monitor (2013), 9 descendants of its own
- K113238: Full Automatic (Nibp) Blood Pressue Monitor (2012), 9 descendants of its own

## Indications for use
The Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U with semiconductor pressure sensor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the wrist. The device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) 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/K061403
Methodology: https://510kreport.com/methodology