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

    LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber

    K Number: K210558 · Decision Apr 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    15
    Applicant Total
    4
    Review Days
    400

    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
    LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber
    K Number
    K210558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thayer Medical Corporation
    Date Received
    February 25, 2021
    Decision Date
    April 1, 2022
    Product Code
    NVP
    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
    NVP Holding Chambers, Direct Patient Interface

    Similar 510(k) Clearances

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

    AeroChamber2go Anti-Static Valved Holding Chamber

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Antistatic Compact Space Chamber

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS

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

    Other Clearances by Thayer Medical Corporation

    K Number Device Name
    K233553 MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
    K160109 Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber
    K111570 MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR