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

    RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder

    K Number: K173279 · Decision May 14, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    12
    Review Days
    213

    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
    RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
    K Number
    K173279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Myco Medical Supplies, Inc.
    Date Received
    October 13, 2017
    Decision Date
    May 14, 2018
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

    Similar 510(k) Clearances

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

    Profoject™ Safety Pen Needles

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Verisafe Safety Sterile Needles (SSN)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRESSONE™

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Safety Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Pen Needle

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

    Other Clearances by Myco Medical Supplies, Inc.

    K Number Device Name
    K203668 RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
    K090426 VAKU-8 BLOOD COLLECTION NEEDLES
    K042504 CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
    K000592 UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET
    K990519 PHOENIX EPIDURAL & SPINAL NEEDLES
    K982646 AILEE SUTURES AND AILEE NEEDLES
    K990388 TUTOPLUS IV ADMINISTRATION SET
    K982098 TUTODROP 1 AND TUTODROP 2
    K963364 GLASS VAN GLASS SYRINGES
    K953252 DISPOSABLE SCALP VEIN INFUSION SET
    Search all 12 clearances from Myco Medical Supplies, Inc. →