# K041411: Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Corp.
- Decided: Jul 21, 2004 after 55 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: 3 generations back to K903134 (1991). 4 ancestors in all.
120 later devices descend from it; 6 cite it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013485: Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with Optional Thermal Printer, Model PR 1KA1, Microlife Corp. (2002) Summary page 1.
- K012472: A & D Medical Lifesource UA-781, UA781PC, & UA-781T Digital Blood Pressure Monitors, A&D Engineering, Inc. (2002) Summary page 1.

## Most influential descendants
- K060686: Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC (2006), 86 descendants of its own
- K081590: YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J (2008), 46 descendants of its own
- K083093: Cheetah Reliant (2008), 45 descendants of its own
- K073198: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp Home (BP3MX1-1) (2008), 36 descendants of its own
- K101487: Cheetah Nicom System (2010), 35 descendants of its own

## Indications for use
The Microlife Upper Arm Blood Pressure Monitor, Model BP 3BT0-AP, 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 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/K041411
Methodology: https://510kreport.com/methodology