# K040002: Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property Gmb
- Decided: Mar 22, 2004 after 80 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: 1 generation back to K021305 (2002). 1 ancestor in all.
28 later devices descend from it; 4 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021305: Microlife Wrist Watch Blood Pressure, Model BP-3BU1-5, with Optional Thermal Printer, Microlife Corp. (2002) Summary page 1.

## Most influential descendants
- K061403: Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U (2006), 20 descendants of its own
- 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

## Indications for use
The Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 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.

Source page: https://510kreport.com/device/K040002
Methodology: https://510kreport.com/methodology