# K133389: EM40 Self-Monitoring Blood Glucose System

- Pathway: 510(k) (Special)
- Applicant: Eps Bio Technology Corp.
- Decided: Apr 15, 2014 after 161 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K190189: MDT2 BLE Self-Monitoring Blood Glucose System (2019), 0 descendants of its own

## Indications for use
The EM4O Pro Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing isdone outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional hsealtlhcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor lbr the diagnosis of. or screening for diabetes mellitus. The system consists of the EM4O Pro meter and the EM40 Pro test strips. The EM4O Pro meter only is used with the EM40 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip. The EM4O Glucose Control Solution For use with the EM40 Pro Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results. The EM4O Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose inl fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (in Vitro diagnostic use). it is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used onl neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions. The system consists of the EM4O meter and the EM4O test strips. The EM40 meter only is used with the EM40 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm. The EM40 Glucose Control Solution is for use with EM40 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K133389
Methodology: https://510kreport.com/methodology