# K091897: Blood Pressure Monitor, Model Fora P11/TD-3019

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Aug 25, 2009 after 62 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
FORA P11/TD-3019 Blood Pressure Monitor is intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.

Source page: https://510kreport.com/device/K091897
Methodology: https://510kreport.com/methodology