BEUDAMED
    Product Code: PYT FDA class 2 21 CFR 884.5370

    Device, Fertility Diagnostic, Contraceptive, Software Application

    Obstetrics/Gynecology

    The Device, Fertility Diagnostic, Contraceptive, Software Application is a software-based device designed to monitor fertility indicators and provide information to prevent pregnancy through contraception, used by individuals seeking a non-pharmacological contraceptive method. It is classified as a Class 2 device under regulation 884.5370, requiring 510(k) premarket notification to demonstrate substantial equivalence before marketing. The product code is PYT, and it falls within the Obstetrics/Gynecology (OB) medical specialty. It is not an implant and is not life-sustaining.

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    510(k)s
    6
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    3
    Years Active
    7

    Basic Information

    Product Code
    PYT
    Device Class
    FDA class 2
    Regulation Number
    884.5370
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Designed to monitor and provide fertility information to prevent pregnancy (contraception).

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 6 510(k) clearances via K numbers.

    K Number Device Name
    K250561 Natural Cycles
    K241006 Natural Cycles
    K231274 Natural Cycles
    K202897 Natural Cycles
    K193330 Clue Birth Control
    DEN170052 Natural Cycles

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.