# K073397: Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50)

- 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970139: Microlife Manual Blood Pressure Monitor  (Manual Inflate) Model BP-2BIO, Micro Weiss Electronics (1998) Summary page 1.
- K041411: Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP, Microlife Corp. (2004)

## Indications for use
The Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric 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/K073397
Methodology: https://510kreport.com/methodology