# K201258: EASYMAX Tag Self-Monitoring Blood Glucose System

- Pathway: 510(k) (Special)
- Applicant: Eps Bio Technology Corp.
- Decided: Sep 1, 2021 after 478 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 K121207 (2012). 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)
- K121207: Easymax MU Self Monitoring Blood Glucose System, Easymax MU Pro Self Monitoring Blood Glucose System, Eps Bio Technology Corp. (2012) Summary page 4.

## Indications for use
The EASYMAX® Tag Self-Monitoring Blood Glucose System is comprised of the EASYMAX® Tag meter and the EASYMAX® Tag test strips. The kit is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the 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 on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

Source page: https://510kreport.com/device/K201258
Methodology: https://510kreport.com/methodology