Cleared Traditional

K101635 - TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM

K101635 is an FDA 510(k) clearance for TD-4239 BLOOD GLUCOSE MONITORING SYSTEM..., manufactured by Taidoc Technology Corporation. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 447-day FDA review.

K101635 · Taidoc Technology Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
447d
Days
Class 2
Risk

K101635 is an FDA 510(k) clearance for the TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONI.... 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 August 31, 2011 after a review of 447 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Taidoc Technology Corporation devices

FDA 510(k) Submission Details - K101635

510(k) Number K101635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2010
Decision Date August 31, 2011
Days to Decision 447 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
359d slower than avg
Panel avg: 88d · This submission: 447d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 360
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