# K112216: U-Right TD-3128 Blood Pressure Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Dec 22, 2011 after 142 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.
2 later devices descend 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)
- 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 2.

## Most influential descendants
- K133588: Fora Care Blood Pressure Monitoring System (2014), 1 descendant of its own
- K182934: FORA P100 Blood Pressure Monitoring System (2019), 0 descendants of its own

## Indications for use
The U-RIGHT TD-3 128 Blood Pressure Monitoring System is intended to be used 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. This system should only be used for the testing on people over 18 years of age and over.

Source page: https://510kreport.com/device/K112216
Methodology: https://510kreport.com/methodology