Cleared Traditional

K011240 - EVENCARE BLOOD GLUCOSE MONITORING SYSTEM

K011240 is an FDA 510(k) clearance for EVENCARE BLOOD GLUCOSE MONITORING SYSTEM, manufactured by Medline Industries, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K011240

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.

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 418
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K011240.
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
K012014 · Abbott Diabetes Care, Inc. · Dec 2001
ACCU-CHEK ACTIVE TEST SYSTEM
K012324 · Roche Diagnostics Corp. · Dec 2001
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
K013203 · Polymer Technology Systems, Inc. · Nov 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