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FDA 510(k)

Libre Rio Continuous Glucose Monitoring System

K-Number: K233861 · 2024-06-07

ApplicantAbbott Diabetes Care
Decision Date2024-06-07
Product CodeSBH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Libre Rio Continuous Glucose Monitoring System is a medical device manufactured by Abbott Diabetes Care. It received FDA 510(k) clearance on 2024-06-07 under approval number K233861. The device is classified under product code SBH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Libre Rio Continuous Glucose Monitoring System?

Libre Rio Continuous Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2024-06-07. It is manufactured by Abbott Diabetes Care. The 510(k) number is K233861.

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

Libre Rio Continuous Glucose Monitoring System received FDA 510(k) clearance on 2024-06-07, under approval number K233861.

What company makes Libre Rio Continuous Glucose Monitoring System?

Libre Rio Continuous Glucose Monitoring System is manufactured by Abbott Diabetes Care.

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

The FDA product code for Libre Rio Continuous Glucose Monitoring System is SBH.

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)

Official Source

View on FDA Database →

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