# K021305: Microlife Wrist Watch Blood Pressure, Model BP-3BU1-5, with Optional Thermal Printer

- Pathway: 510(k) (Special)
- Applicant: Microlife Corp.
- Decided: Jun 28, 2002 after 65 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
No predicates in its family tree.
57 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Microlife Automatic Wrist Watch Blood Pressure Monitor, Model BP-3BU1: named in the summary without a submission number
- (no number) Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with Optional Thermal Printer, Model PRI KA1: named in the summary without a submission number

## Most influential descendants
- K061471: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC (2006), 32 descendants of its own
- K040002: Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 (2004), 28 descendants of its own
- 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
- K140572: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2014), 18 descendants of its own

## Indications for use
The Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1-5 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. This device can be used in connection with the Microlife Thermal Printer, Model PR 1KA1.

Source page: https://510kreport.com/device/K021305
Methodology: https://510kreport.com/methodology