Cleared Traditional

K011240 - EVENCARE BLOOD GLUCOSE MONITORING SYSTEM

K011240 is the FDA 510(k) clearance for EVENCARE BLOOD GLUCOSE MONITORING SYSTEM by Medline Industries, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K011240 · Medline Industries, Inc. · Chemistry device
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Sep 2001
Decision
143d
Days
Class 2
Risk

K011240 is an FDA 510(k) clearance for the 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 September 13, 2001 after a review of 143 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K011240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2001
Decision Date September 13, 2001
Days to Decision 143 days
Submission Type Traditional
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
55d slower than avg
Panel avg: 88d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K011240.
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ACCU-CHEK ACTIVE TEST SYSTEM
K012324 · Roche Diagnostics Corp. · Dec 2001
GLUCOMETER DEX TEST SENSOR
K012205 · Bayer Corp. · Sep 2001
MODIFICATION TO ACCU-CHEK INFORM METER
K012210 · Roche Diagnostics Corp. · Aug 2001
ACCU-CHEK ACTIVE SYSTEM
K011738 · Roche Diagnostics Corp. · Jun 2001