Cleared Special

K121087 - CONTOUR NEXT USB BLOOD GLUCOSE MONITORI...

K121087 is the FDA 510(k) clearance for CONTOUR NEXT USB BLOOD GLUCOSE MONITORI... by Bayer Healthcare. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 79-day FDA review.

K121087 · Bayer Healthcare · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
79d
Days
Class 2
Risk

K121087 is an FDA 510(k) clearance for the CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM. 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 June 28, 2012 after a review of 79 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 K121087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2012
Decision Date June 28, 2012
Days to Decision 79 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
9d faster than avg
Panel avg: 88d · This submission: 79d
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 K121087.
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
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BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM
K113077 · Taidoc Technology Corporation · Aug 2012
AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
K120649 · Apex BioTechnology Corp. · Jul 2012
HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM
K110074 · Health & Life Co., Ltd. · May 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
K120568 · Abbott Diabetes Care, Inc. · Mar 2012
NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
K112638 · Nova Biomedical Corporation · Mar 2012