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) Official FDA 510(k) Summary (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.

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
142d slower than avg
Panel avg: 89d · 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 513
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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SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System
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Gmate SMART Blood Glucose Monitoring System
K150299 · Philosys, Inc. · Nov 2015
Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips
K150396 · Apex BioTechnology Corp. · Oct 2015
K150942 · Contour Next USB Blood Glucose Monitoring System
Download PDF FDA Summary Bayer Healthcare