Cleared Special

K123517 - GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K123517 · Sd Biosensor · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
429d
Days
Class 2
Risk

K123517 is an FDA 510(k) clearance for the GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE .... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Sd Biosensor (Great Neck, US). The FDA issued a Cleared decision on January 17, 2014 after a review of 429 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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.

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Submission Details

510(k) Number K123517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2012
Decision Date January 17, 2014
Days to Decision 429 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
341d slower than avg
Panel avg: 88d · This submission: 429d
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 507
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