# K062538: Easy Check Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Diacare Corp.
- Decided: Apr 30, 2007 after 244 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: 2 generations back to K964630 (1997). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043311: Ascensia Elite Diabetes Care System, Bayer Healthcare, LLC (2004) Summary page 1.

## Most influential descendants
- K090389: AP-1000 Blood Glucose Monitoring System (2009), 4 descendants of its own
- K103230: AP-3000 Blood Glucose Monitoring System, Major Glucose Control Solution (2012), 0 descendants of its own
- K103116: AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring System (2012), 0 descendants of its own
- K103044: AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose Control Solution (2012), 0 descendants of its own
- K100437: AP-1000 Blood Glucose Monitoring System, Model AP-1000, Major Glucose Control Solution (2012), 0 descendants of its own

## Indications for use
The EASY CHECK Blood Glucose Monitoring Systems is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and healthcare facilities as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The EASY CHECK Control Solution is intended for in vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the EASY CHECK Blood Glucose Monitor System.

Source page: https://510kreport.com/device/K062538
Methodology: https://510kreport.com/methodology