# K043245: Eps Easy Pain Supreme Self Monitoring Blood Glucose System

- Pathway: 510(k) (Traditional)
- Applicant: Eps Bio Technology Corp.
- Decided: Apr 29, 2005 after 157 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
Longest line of descent: 4 generations back to K945887 (1995). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971812: Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip, Medisense, Inc. (1997) Summary page 1.

## Most influential descendants
- K061992: Easyplus Self Monitoring Glucose Test System, Model EPS04014 (2006), 1 descendant of its own
- K081796: Easyplus Mini R2N Self Monitoring Glucose Test System (2009), 0 descendants of its own

## Indications for use
The Easy Pain Supreme Self-Monitoring Blood Glucose System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in fresh capillary whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.

Source page: https://510kreport.com/device/K043245
Methodology: https://510kreport.com/methodology