# K052818: EZ Smart-168 Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Tyson Bioresearch, Inc.
- Decided: Jun 16, 2006 after 255 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)
- K040848: EZ Smart, Vip International Wholesalers, Corp. (2004) Summary page 1.

## Most influential descendants
- K062829: Diachex Blood Glucose Monitoring System (2006), 4 descendants of its own
- K073492: Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose Monitoring System (2008), 3 descendants of its own
- K090629: Easy Step and Diachex+ Pro Blood Glucose Monitoring Systems (2009), 2 descendants of its own
- K101543: Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200 (2011), 1 descendant of its own
- K123087: Tysonbio AC500, AC800 Blood Glucose Monitoring System, Tysonbio AC500 AC800 Pro Blood Glucose Monitoring System (2013), 0 descendants of its own

## Indications for use
The EZ Smart-168 Blood Glucose Test Strips are used with the EZ Smart-168 Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The EZ Smart-168 Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Smart-168 Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels in persons with diabetes.

Source page: https://510kreport.com/device/K052818
Methodology: https://510kreport.com/methodology