BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇻 El Salvador

    Laboratorios Biogalenic Sterile Water for Inhalation, USP

    K Number: K242717 · Decision Jan 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    3
    Review Days
    142

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Laboratorios Biogalenic Sterile Water for Inhalation, USP
    K Number
    K242717
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Laboratorios Biogalenic S.A. DE C.V.
    Date Received
    September 10, 2024
    Decision Date
    January 30, 2025
    Product Code
    BTT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BTT), ordered by most recent decision date.

    HVT 2.0

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FL-10000U Respiratory Humidifier

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Laboratorios Biogalenic Sterile Water for Inhalation, USP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Laboratorios Biogalenic S.A. DE C.V.

    K Number Device Name
    K251419 Laboratorios Biogalenic Sterile Water for Inhalation, USP
    K243001 Sterile Water USP and Sterile 0.9% Normal Saline USP