# K091814: Fora D20 Blood Glucose Plus Blood Pressure Monitoring System; TD-3263 Blood Glucose Plus Blood Pressure Monitoring Syste

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Nov 20, 2009 after 155 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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
The FORA D20/TD-3263 Blood Glucose plus Blood Pressure Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, or for testing on neonates. The alternative site testing in this system can be used only during steady-state blood glucose conditions. The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" - 13.8". This meter has some speaking functions but is not intended for use by the visually impaired

Source page: https://510kreport.com/device/K091814
Methodology: https://510kreport.com/methodology