Libre Rio Continuous Glucose Monitoring System

FDA 510(k) K233861 · Abbott Diabetes Care

Substantially Equivalent

510(k) numberK233861

Submission

Device name
Libre Rio Continuous Glucose Monitoring System
Applicant
Abbott Diabetes Care
Alameda, CA, US
Received
December 6, 2023
Decision date
June 7, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
SBH – Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1355
Specialty
Clinical Chemistry

An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose management is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels across the range spanning clinically significant hypoglycemia and hyperglycemia levels in persons who are not on insulin and who do…

Other 510(k)s with product code SBH

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K262472Stelo Glucose Biosensor SystemSBH · Special Dexcom, Inc.08/11/2026SE
K260935Stelo Glucose Biosensor SystemSBH · Traditional Dexcom, Inc.06/12/2026SE

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Questions and answers

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

Libre Rio Continuous Glucose Monitoring System (K233861) received a 510(k) decision of Substantially Equivalent on June 7, 2024, 184 days after the submission was received.

What is the product code of K233861?

The FDA product code is SBH – Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1355.