Cleared Special

K080501 - SURECHEK EDGE BLOOD GLUCOSE MONITORING ...

K080501 is the FDA 510(k) clearance for SURECHEK EDGE BLOOD GLUCOSE MONITORING ... by Taidoc Technology Corporation. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 56-day FDA review.

K080501 · Taidoc Technology Corporation · Chemistry device
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Apr 2008
Decision
56d
Days
Class 2
Risk

K080501 is an FDA 510(k) clearance for the SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (Taipei County, TW). The FDA issued a Cleared decision on April 21, 2008 after a review of 56 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Taidoc Technology Corporation devices

Submission Details

510(k) Number K080501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2008
Decision Date April 21, 2008
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
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 235
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K080501.
CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243
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GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1
K073137 · Apex BioTechnology Corp. · Apr 2008