# K043340: EZ Smart

- Pathway: 510(k) (Traditional)
- Applicant: Vip Diagnostics, LLC
- Decided: Jun 2, 2005 after 181 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). 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)
- K040848: EZ Smart, Vip International Wholesalers, Corp. (2004) Summary page 2.
- K984006: Glucometer Elite XL Blood Glucose Meter, Bayer Corp. (1999) Summary page 2.
- K964630: Glucometer Elite Blood Glucose Meter, Bayer Corp. (1997) Summary page 2.
- K991242: Glucometer Elite Test Strips, Bayer Corp. (1999) Summary page 2.

## Indications for use
The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in the 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. The EZ Smart Blood Glucose Monitoring System is indicated for use with capillary whole blood samples drawn from the fingertips and forearm.

Source page: https://510kreport.com/device/K043340
Methodology: https://510kreport.com/methodology