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

    RAPID-FILL TUBESET, MODEL 90005

    K Number: K022523 · Decision Aug 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    8
    Review Days
    13

    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
    RAPID-FILL TUBESET, MODEL 90005
    K Number
    K022523
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxa Corp.
    Date Received
    July 30, 2002
    Decision Date
    August 12, 2002
    Product Code
    LHI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LHI Set, I.V. Fluid Transfer

    Similar 510(k) Clearances

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

    ADRx™ Admixture Device

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Vial Adapter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Medline Bag Decanter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FlowArt® Vial Access Device Vented

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HyHub™ and HyHub™ Duo Vial Access Devices

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Baxa Corp.

    K Number Device Name
    K090917 SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
    K070163 SWABBABLE CAP, MODEL 60205
    K062909 REPEATER PUMP II TUBE SETS
    K002705 EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
    K983321 MICROFUSE DUAL RATE INFUSER
    K951871 PISTON SYRINGE
    K933506 SYRINGE INFUSER