Cleared Special

K150942 - Contour Next USB Blood Glucose Monitoring System

K150942 is an FDA 510(k) clearance for Contour Next USB Blood Glucose Monitori..., manufactured by Bayer Healthcare. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 231-day FDA review.

K150942 · Bayer Healthcare · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
231d
Days
Class 2
Risk

K150942 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 November 25, 2015 after a review of 231 days - an extended review 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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K150942

510(k) Number K150942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2015
Decision Date November 25, 2015
Days to Decision 231 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
143d slower than avg
Panel avg: 88d · This submission: 231d
Pathway characteristics
Modification to existing cleared device.

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 420
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K150942.
OneTouch Ultra Plus Flex Blood Glucose Monitoring System
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