Cleared Special

K092894 - EASYMAX V SELF MONITORING BLOOD GLUCOSE...

K092894 is an FDA 510(k) clearance for EASYMAX V SELF MONITORING BLOOD GLUCOSE..., manufactured by Eps Bio Technology Corp.. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 156-day FDA review.

K092894 · Eps Bio Technology Corp. · Chemistry device
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Feb 2010
Decision
156d
Days
Class 2
Risk

K092894 is an FDA 510(k) clearance for the EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Eps Bio Technology Corp. (Hsinchu City, TW). The FDA issued a Cleared decision on February 24, 2010 after a review of 156 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Eps Bio Technology Corp. devices

FDA 510(k) Submission Details - K092894

510(k) Number K092894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2009
Decision Date February 24, 2010
Days to Decision 156 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 88d · This submission: 156d
Pathway characteristics
Modification to existing cleared device.

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 275
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K092894.
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