Cleared Special

K091820 - CONTOUR USB BLOOD GLUCOSE METER

Also marketed or referenced as:
GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM

K091820 is the FDA 510(k) clearance for CONTOUR USB BLOOD GLUCOSE METER by Bayer Healthcare. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 69-day FDA review.

K091820 · Bayer Healthcare · Chemistry device
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Aug 2009
Decision
69d
Days
Class 2
Risk

K091820 is an FDA 510(k) clearance for the CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bayer Healthcare (Mishawaka, US). The FDA issued a Cleared decision on August 26, 2009 after a review of 69 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 Bayer Healthcare devices

Submission Details

510(k) Number K091820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2009
Decision Date August 26, 2009
Days to Decision 69 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
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 K091820.
NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254
K092099 · Taidoc Technology Corporation · Dec 2009
DIDGET BLOOD GLUCOSE METER, MODEL 6181
K090628 · Bayer Healthcare, LLC · Dec 2009
BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234
K091898 · Taidoc Technology Corporation · Sep 2009
U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222
K090188 · Taidoc Technology Corporation · Jul 2009
FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247
K090404 · Taidoc Technology Corporation · Jun 2009
FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
K090187 · Taidoc Technology Corporation · May 2009