Cleared Special

K123517 - GLUCOMENTOR BLOOD GLUCOSE MONITORING SY...

K123517 is the FDA 510(k) clearance for GLUCOMENTOR BLOOD GLUCOSE MONITORING SY... by Sd Biosensor. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 429-day FDA review.

K123517 · Sd Biosensor · Chemistry device
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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.

View all Sd Biosensor devices

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 236
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K123517.
ACCU-CHEK Performa Blood Glucose Monitoring System
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K133790 · Andon Health Co, Ltd. · May 2014
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K131469 · ACON Laboratories, Inc. · Jan 2014
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K132511 · Abbott Diabetes Care, Inc. · Dec 2013
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
K130284 · ACON Laboratories, Inc. · Dec 2013