Cleared Special

K152442 - Freestyle Freedom Blood Glucose Monitoring Sytem (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K152442 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
112d
Days
Class 2
Risk

K152442 is an FDA 510(k) clearance for the Freestyle Freedom Blood Glucose Monitoring Sytem. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Abbott Laboratories (Alameda, US). The FDA issued a Cleared decision on December 17, 2015 after a review of 112 days - within the typical 510(k) review window.

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 Abbott Laboratories devices

Submission Details

510(k) Number K152442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2015
Decision Date December 17, 2015
Days to Decision 112 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
24d slower than avg
Panel avg: 88d · This submission: 112d
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 507
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K152442.
On Call® Sure GK Blood Glucose & Ketone Monitoring System
K250085 · ACON Laboratories, Inc. · Oct 2025
TeleRPM Gen2 Blood Glucose Monitoring System
K243060 · Guangdong Transtek Medical Electronics Co., Ltd. · Jan 2025
RIGHTEST Blood Glucose Monitoring System Max Tel
K240637 · Bionime Corporation · Nov 2024
Sejoy Blood Glucose Monitoring System
K240640 · Sejoy Biomedical Co., Ltd. · Oct 2024
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
K241787 · Ascensia Diabetes Care U.S., Inc. · Aug 2024
VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System
K222126 · Vivachek Biotech (Hangzhou) Co., Ltd. · Aug 2024