# K133588: Fora Care Blood Pressure Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Foracare, Inc.
- Decided: Apr 25, 2014 after 155 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: 6 generations back to K982481 (1998). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112216: U-Right TD-3128 Blood Pressure Monitoring System, Taidoc Technology Corporation (2011) Summary page 2.

## Most influential descendants
- K182934: FORA P100 Blood Pressure Monitoring System (2019), 0 descendants of its own

## Indications for use
Fora Care Blood Pressure Monitoring System is a system designed to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. It is intended for individuals age I8 and above use at home and in clinical settings. The device is not to be used for the diagnosis of hypertension or for testing on newborns.

Source page: https://510kreport.com/device/K133588
Methodology: https://510kreport.com/methodology