Cleared Traditional

K222447 - FreeStyle Libre 2 Flash Glucose Monitoring System (FDA 510(k) Clearance)

Also includes:
Freestyle Libre 3 Continuous Glucose Monitoring System

Class II Chemistry device cleared through predicate-based substantial equivalence.

K222447 · Abbott Diabetes Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
200d
Days
Class 2
Risk

K222447 is an FDA 510(k) clearance for the FreeStyle Libre 2 Flash 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 March 3, 2023 after a review of 200 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 K222447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2022
Decision Date March 03, 2023
Days to Decision 200 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
112d slower than avg
Panel avg: 88d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05251116 Completed Interventional Industry-sponsored

Study of an Interstitial Fluid Glucose Sensor

Accuracy Study of an Interstitial Fluid Glucose Sensor

332
Patients (actual)
5
Sites
Other
Purpose
Open label
Masking
Condition studied Diabete Mellitus
Study design Single group
Eligibility All sexes · 2 Years+
Principal investigator Shridhara A Karinka, PhD
Sponsor Abbott Diabetes Care (industry)
Started 2021-12-11 → Primary completion 2022-07-20 → Completed 2022-08-15
Primary outcome
System Performance
Study completed - no results published. This trial concluded in 2022 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

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 K222447.
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
FreeStyle Libre 3 Continuous Glucose Monitoring System
K233537 · Abbott Diabetes Care, Inc. · Apr 2024
Dexcom G7 Continuous Glucose Monitoring System
K240902 · Dexcom, Inc. · Apr 2024
Dexcom G7 Continuous Glucose Monitoring System
K234133 · Dexcom, Inc. · Feb 2024