Cleared Special

K090536 - FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247

K090536 is an FDA 510(k) clearance for FORA V12 NO-CODING BLOOD GLUCOSE MONITO..., manufactured by Taidoc Technology Corporation. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 27-day FDA review.

K090536 · Taidoc Technology Corporation · Chemistry device
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Mar 2009
Decision
27d
Days
Class 2
Risk

K090536 is an FDA 510(k) clearance for the FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on March 26, 2009 after a review of 27 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.

FDA 510(k) Submission Details - K090536

510(k) Number K090536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2009
Decision Date March 26, 2009
Days to Decision 27 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
62d faster than avg
Panel avg: 89d · This submission: 27d
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 513
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K090536.
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM
K090185 · Taidoc Technology Corporation · Apr 2009
ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
K090057 · Acon Laboratories Co. · Apr 2009
TRUEBALANCE BLOOD GLUCOSE SYSTEM
K090495 · Home Diagnostics, Inc. · Mar 2009
BETACHEK GLUCOSE TEST
K062187 · National Diagnostic Products · Mar 2009
SYMCARE DIABETES MANAGEMENT PROGRAM
K083263 · Symcare Personalized Health Solutions, Inc. · Mar 2009
GLUCODR PLUS SYSTEM, MODEL AGM-3000
K082328 · All Medicus Co., Ltd. · Feb 2009
K090536 · FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247
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