Cleared Special

K042005 - ACHTUNG TD-4207

K042005 is the FDA 510(k) clearance for ACHTUNG TD-4207 by Taidoc Technology Corporation. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 32-day FDA review.

K042005 · Taidoc Technology Corporation · Chemistry device
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Aug 2004
Decision
32d
Days
Class 2
Risk

K042005 is an FDA 510(k) clearance for the ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (San Chung, Taipei, TW). The FDA issued a Cleared decision on August 27, 2004 after a review of 32 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 K042005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2004
Decision Date August 27, 2004
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
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 K042005.
CLEVER CHEK TD-3213
K042795 · Taidoc Technology Corporation · Mar 2005
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
K043158 · Bayer Healthcare, LLC · Dec 2004
ASCENSIA ELITE DIABETES CARE SYSTEM
K043311 · Bayer Healthcare, LLC · Dec 2004
TAIDOC CHECK
K041107 · Taidoc Technology Corporation · Jun 2004
PARADIGM LINK BLOOD GLUCOSE METER
K040603 · Becton, Dickinson & CO · May 2004
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K040814 · Abbott Laboratories · Apr 2004