# K073398: Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)

- Pathway: 510(k) (Special)
- Applicant: Microlife Corp.
- Decided: Dec 20, 2007 after 17 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: 4 generations back to K903134 (1991). 6 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001182: Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1, Microlife Corp. (2000)
- K041411: Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP, Microlife Corp. (2004) Summary page 1.

## Most influential descendants
- K120430: Microlife Wrist Watch Blood Preeure Monitor, BP3MO1-3P (2012), 4 descendants of its own
- K151330: Microlife Wrist Watch Blood Pressure Monitor (2015), 2 descendants of its own
- K091415: Truly  Automatic Wrist Blood Pressure Monitor, Model DW100,DW200, DW500,DW700,DW703,DW701M.702M (2009), 2 descendants of its own
- K211288: Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B (2021), 1 descendant of its own
- K092456: Microlife Wrist Watch Blood Pressure Monitor, Model BP3BS1-3C (2009), 1 descendant of its own

## Indications for use
The Microlife Wrist Watch Blood Pressure Monitor, Model BP 3MK1-3 (BP W100) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. 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/K073398
Methodology: https://510kreport.com/methodology