Cleared Traditional

K090188 - U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE...

K090188 is the FDA 510(k) clearance for U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE... by Taidoc Technology Corporation. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K090188 · Taidoc Technology Corporation · Chemistry device
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Jul 2009
Decision
168d
Days
Class 2
Risk

K090188 is an FDA 510(k) clearance for the U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222. 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 July 13, 2009 after a review of 168 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. 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 Taidoc Technology Corporation devices

Submission Details

510(k) Number K090188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2009
Decision Date July 13, 2009
Days to Decision 168 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 88d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K090188.
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FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
K090187 · Taidoc Technology Corporation · May 2009
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM
K090185 · Taidoc Technology Corporation · Apr 2009