Cleared Special

K031843 - MODIFICATION TO EVENCARE BLOOD GLUCOSE ...

K031843 is the FDA 510(k) clearance for MODIFICATION TO EVENCARE BLOOD GLUCOSE ... by Medline Industries, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 17-day FDA review.

K031843 · Medline Industries, Inc. · Chemistry device
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Jul 2003
Decision
17d
Days
Class 2
Risk

K031843 is an FDA 510(k) clearance for the MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on July 3, 2003 after a review of 17 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K031843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2003
Decision Date July 03, 2003
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
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 235
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K031843.
PRECISION XCEED DIABETES MONITORING SYSTEM
K033845 · Abbott Laboratories · Jan 2004
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005
K031260 · Abbott Diabetes Care, Inc. · Dec 2003
ACCU-CHEK ADVANTAGE SYSTEM
K032552 · Roche Diagnostics Corp. · Sep 2003
PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO
K023256 · Abbott Laboratories · Apr 2003
ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS
K024194 · Lifescan, Inc. · Feb 2003
ASCENSIA GLUCOFACTS
K024234 · Bayer Corp. · Jan 2003