Cleared Traditional

K061181 - ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207

K061181 is an FDA 510(k) clearance for ACHTUNG 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 70-day FDA review.

K061181 · Taidoc Technology Corporation · Chemistry device
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Jul 2006
Decision
70d
Days
Class 2
Risk

K061181 is an FDA 510(k) clearance for the ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207. 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 July 6, 2006 after a review of 70 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K061181

510(k) Number K061181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2006
Decision Date July 06, 2006
Days to Decision 70 days
Submission Type Traditional
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
19d faster than avg
Panel avg: 89d · This submission: 70d
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 513
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K061181.
ELEMENT BLOOD GLUCOSE TEST SYSTEM
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PRODIGY
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K052818 · Tyson Bioresearch, Inc. · Jun 2006
THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
K061328 · E-San Limited · Jun 2006
GLUCOPACK
K052469 · Healthpia America Corp. · Jun 2006
K061181 · ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
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