Cleared Traditional

K040848 - EZ SMART

K040848 is an FDA 510(k) clearance for EZ SMART, manufactured by Vip International Wholesalers, Corp.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K040848 · Vip International Wholesalers, Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 2004
Decision
132d
Days
Class 2
Risk

K040848 is an FDA 510(k) clearance for the EZ SMART. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Vip International Wholesalers, Corp. (Washington, US). The FDA issued a Cleared decision on August 11, 2004 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Vip International Wholesalers, Corp. devices

FDA 510(k) Submission Details - K040848

510(k) Number K040848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2004
Decision Date August 11, 2004
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBW Device Classification - Class 2, Special Controls

Product Code NBW System, Test, Blood Glucose, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 356
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K040848.
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K042005 · Taidoc Technology Corporation · Aug 2004
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TAIDOC CHECK
K041107 · Taidoc Technology Corporation · Jun 2004
PARADIGM LINK BLOOD GLUCOSE METER
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