BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Stelo Glucose Biosensor System

    K Number: K260935 · Decision Jun 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    27
    Review Days
    84

    Basic Information

    Device Name
    Stelo Glucose Biosensor System
    K Number
    K260935
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1355
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dexcom, Inc.
    Date Received
    March 20, 2026
    Decision Date
    June 12, 2026
    Product Code
    SBH
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SBH Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

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    Other Clearances by Dexcom, Inc.

    K Number Device Name
    K261402 Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System
    K261359 Stelo Glucose Biosensor System
    K253737 Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
    K253710 Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
    K252818 Dexcom Smart Basal
    K243214 Dexcom G7 15 Day Continuous Glucose Monitoring System
    K240902 Dexcom G7 Continuous Glucose Monitoring System
    K234070 Stelo Glucose Biosensor System
    K234133 Dexcom G7 Continuous Glucose Monitoring System
    K231081 Dexcom G7 Continuous Glucose Monitoring (CGM) System
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