Cleared Special

EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM (K092894) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 88d · This submission: 156d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 166
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K092894.
MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K091555 · Taidoc Technology Corporation · Mar 2010
U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC
K092902 · Taidoc Technology Corporation · Mar 2010
ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
K093592 · Taidoc Technology Corporation · Feb 2010
FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM
K093712 · Taidoc Technology Corporation · Feb 2010
MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
K093635 · Taidoc Technology Corporation · Feb 2010
FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264
K093005 · Taidoc Technology Corporation · Feb 2010