Cleared Traditional

K233537 - FreeStyle Libre 3 Continuous Glucose Monitoring System (FDA 510(k) Clearance)

Also includes:
FreeStyle Libre 2 Flash Glucose Monitoring System

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233537 · Abbott Diabetes Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
172d
Days
Class 2
Risk

K233537 is an FDA 510(k) clearance for the FreeStyle Libre 3 Continuous Glucose Monitoring System. Classified as Integrated Continuous Glucose Monitoring System, Factory Calibrated (product code QBJ), Class II - Special Controls.

Submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on April 23, 2024 after a review of 172 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1355 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Diabetes Care, Inc. devices

Submission Details

510(k) Number K233537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2023
Decision Date April 23, 2024
Days to Decision 172 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
84d slower than avg
Panel avg: 88d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1355
Definition An Integrated Continuous Glucose Monitoring System (icgm) Is Intended To Automatically Measure Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. Icgm Systems Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Including Automated Insulin Dosing Systems, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices For The Purpose Of Managing A Disease Or Condition Related To Glycemic Control.
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 - QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated

All 16
Devices cleared under the same product code (QBJ) and FDA review panel - the closest regulatory comparables to K233537.
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K253737 · Dexcom, Inc. · Feb 2026
Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
K253710 · Dexcom, Inc. · Dec 2025
Dexcom G7 15 Day Continuous Glucose Monitoring System
K243214 · Dexcom, Inc. · Apr 2025
Dexcom G7 Continuous Glucose Monitoring System
K240902 · Dexcom, Inc. · Apr 2024
Dexcom G7 Continuous Glucose Monitoring System
K234133 · Dexcom, Inc. · Feb 2024
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K231081 · Dexcom, Inc. · May 2023