# K101926: Fora D40 Blood Glucose Plus Blood Pressure Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Dec 20, 2011 after 529 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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
Longest line of descent: 1 generation back to K091555 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091555: Model TD-3252 Blood Glucose Plus Blood Pressure Monitoring System, Taidoc Technology Corporation (2010) Summary page 1.

## Indications for use
The FORA D4Od Blood Glucose plus Blood Pressure Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm. This system is intended to be used by a single person and should not be shared. The FORA D4Od Blood Glucose plus Blood Pressure Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The FORA D4Od Test Strips are for use with the FORA D4Od Blood Glucose plus Blood Pressure Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm. This 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 an inflatable cuff wrapped around the arm. This system contains speaking function, but is not intended for use by the visually impaired. The FORA Wisdom D4Od Blood Glucose plus Blood Pressure Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm. This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use auto-disabling lancing devices. The FORA Wisdom D4Od Blood Glucose plus Blood Pressure Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, and upper arm should be done only during steady-state times (when glucose is not changing rapidly). The FORA Wisdom D4Od Test Strips are for use with the FORA Wisdom D4Od Blood Glucose plus Blood Pressure Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm. This 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 an inflatable cuff wrapped around the arm. This system contains speaking function, but is not intended for use by the visually impaired.

Source page: https://510kreport.com/device/K101926
Methodology: https://510kreport.com/methodology