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FDA 510(k)

FreeStyle Libre 3 Continuous Glucose Monitoring System

K-Number: K213996 · 2022-05-26

ApplicantAbbott Diabetes Care, Inc.
Decision Date2022-05-26
Product CodeQLG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FreeStyle Libre 3 Continuous Glucose Monitoring System is a medical device manufactured by Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2022-05-26 under approval number K213996. The device is classified under product code QLG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FreeStyle Libre 3 Continuous Glucose Monitoring System?

FreeStyle Libre 3 Continuous Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-05-26. It is manufactured by Abbott Diabetes Care, Inc.. The 510(k) number is K213996.

When was FreeStyle Libre 3 Continuous Glucose Monitoring System approved by the FDA?

FreeStyle Libre 3 Continuous Glucose Monitoring System received FDA 510(k) clearance on 2022-05-26, under approval number K213996.

What company makes FreeStyle Libre 3 Continuous Glucose Monitoring System?

FreeStyle Libre 3 Continuous Glucose Monitoring System is manufactured by Abbott Diabetes Care, Inc..

What is the FDA product code for FreeStyle Libre 3 Continuous Glucose Monitoring System?

The FDA product code for FreeStyle Libre 3 Continuous Glucose Monitoring System is QLG.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07599982 Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes RECRUITING NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41693672 Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report. Journal of diabetes science and technology (2026) PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 39670276 Multicenter Evaluation of Machine-Learning Continuous Pulse Rate Algorithm on Wrist-Worn Device. Digital biomarkers (2024) PMID: 37272495 An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection. Journal of diabetes science and technology (2025)

Other Devices by Abbott Diabetes Care, Inc.

K153330FreeStyle Precision Neo H Blood Glucose Monitoring System K171941FreeStyle Precision Neo Blood Glucose Test Strips K193371FreeStyle Libre 2 Flash Glucose Monitoring System K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) K211102FreeStyle Libre 2 Flash Glucose Monitoring System K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

View all 14 devices →

Related Devices (Code: QLG)

K193371FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc. K211102FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc. K202145Bigfoot Unity Diabetes Management SystemBigfoot Biomedical, Inc. K212132FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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