# K072441: EZ Scan Plus Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Tyson Bioresearch, Inc.
- Decided: Mar 25, 2008 after 208 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: 3 generations back to K964630 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052818: EZ Smart-168 Glucose Monitoring System, Tyson Bioresearch, Inc. (2006) Summary page 2.

## Indications for use
The EZ Scan Plus Blood Glucose Test Strips are used with the EZ Scan Plus Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood drawn from the fingertip and the alternate sites: palm and forearm. The EZ Scan Plus Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Scan Plus Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control.

Source page: https://510kreport.com/device/K072441
Methodology: https://510kreport.com/methodology