# K040848: EZ Smart

- Pathway: 510(k) (Traditional)
- Applicant: Vip International Wholesalers, Corp.
- Decided: Aug 11, 2004 after 132 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 K964630 (1997). 2 ancestors in all.
8 later devices descend from it; 2 cite 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)
- K964630: Glucometer Elite Blood Glucose Meter, Bayer Corp. (1997) Summary page 2.
- K991242: Glucometer Elite Test Strips, Bayer Corp. (1999) Summary page 2.

## Most influential descendants
- K052818: EZ Smart-168 Glucose Monitoring System (2006), 6 descendants of its own
- 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

## Indications for use
The EZ Smart Blood Glucose Test Strips are uses with the EZ Smart Meter to measure Glucose (sugar) in whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use ). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics.

Source page: https://510kreport.com/device/K040848
Methodology: https://510kreport.com/methodology