Cleared Traditional

K130265 - CONTOUR NEXT EZ BLOOD GLUCOSE METER

K130265 is an FDA 510(k) clearance for CONTOUR NEXT EZ BLOOD GLUCOSE METER, manufactured by Bayer Healthcare, LLC. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 504-day FDA review.

K130265 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
504d
Days
Class 2
Risk

K130265 is an FDA 510(k) clearance for the CONTOUR NEXT EZ BLOOD GLUCOSE METER. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Mishawaka, US). The FDA issued a Cleared decision on June 23, 2014 after a review of 504 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Bayer Healthcare, LLC devices

FDA 510(k) Submission Details - K130265

510(k) Number K130265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2013
Decision Date June 23, 2014
Days to Decision 504 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
416d slower than avg
Panel avg: 88d · This submission: 504d
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 510
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