# K122013: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Cardio+ (BP4GAPO-2M)

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Corp.
- Decided: May 13, 2013 after 307 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: 7 generations back to K001670 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060686: Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC, Microlife Intellectual Property GmbH (2006) Summary page 1.
- K102939: Fully Automatic Electronic Blood Pressure Monitor Model KD-931, Andon Health Co, Ltd. (2011) Summary page 1.

## Indications for use
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ (BP4GAPO-2M) is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual by using a non-invasive oscillometric technique in one inflatable cuff is wrapped around the single upper arm. The Cardio+ (BP4GAPO-2M) achieves its function by integrating the device with an iPhone, iPad, or iPod Touch. The device can be used in connection with your personal computer (PC) running the software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.

Source page: https://510kreport.com/device/K122013
Methodology: https://510kreport.com/methodology