# K110044: Fora P30 Plus Multi-Mode Blood Pressure Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Foracare, Inc.
- Decided: Jul 7, 2011 after 182 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: 5 generations back to K982481 (1998). 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)
- K092106: U-Right TD-3132 Blood Pressure Monitor, Fora P 20 Blood Pressure Monitor, Model TD-3132, TD-3132, Taidoc Technology Corporation (2010) Summary page 1.

## Indications for use
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System is a device intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual. The blood pressure is measured by using an inflatable cuff wrapped around the arm. This system should be used for the testing on people over age of 18. 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/K110044
Methodology: https://510kreport.com/methodology