Cleared Traditional

K110709 - ARK CARE DIABETES MANAGMENT SYSTEM

K110709 is an FDA 510(k) clearance for ARK CARE DIABETES MANAGMENT SYSTEM, manufactured by Arkray Factory USA, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K110709 · Arkray Factory USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
66d
Days
Class 2
Risk

K110709 is an FDA 510(k) clearance for the ARK CARE DIABETES MANAGMENT SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Arkray Factory USA, Inc. (Edina, US). The FDA issued a Cleared decision on May 19, 2011 after a review of 66 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.

View all Arkray Factory USA, Inc. devices

FDA 510(k) Submission Details - K110709

510(k) Number K110709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2011
Decision Date May 19, 2011
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 88d · This submission: 66d
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 310
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