Cleared Special

K090404 - FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247

K090404 is an FDA 510(k) clearance for FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, 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 126-day FDA review.

K090404 · Taidoc Technology Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
126d
Days
Class 2
Risk

K090404 is an FDA 510(k) clearance for the FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUC.... 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 June 23, 2009 after a review of 126 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K090404

510(k) Number K090404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2009
Decision Date June 23, 2009
Days to Decision 126 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
37d slower than avg
Panel avg: 89d · This submission: 126d
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 K090404.
POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09
K091296 · Polymap Wireless · Jul 2009
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM
K090389 · Bestgen Biotech Corp. · Jul 2009
U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222
K090188 · Taidoc Technology Corporation · Jul 2009
EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS
K090629 · Tyson Bioresearch, Inc. · Jun 2009
FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
K090187 · Taidoc Technology Corporation · May 2009
GLUCODR AUTO SYSTEM
K083628 · All Medicus Co., Ltd. · May 2009
K090404 · FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247
Download PDF Taidoc Technology Cor…