BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    PRIMED Pediatric Facemask

    K Number: K213427 · Decision Nov 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    8
    Applicant Total
    8
    Review Days
    397

    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
    PRIMED Pediatric Facemask
    K Number
    K213427
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Primed Medical Products, Inc.
    Date Received
    October 21, 2021
    Decision Date
    November 22, 2022
    Product Code
    OXZ
    Advisory Committee
    General, Plastic Surgery
    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
    OXZ Pediatric/Child Facemask

    Similar 510(k) Clearances

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

    Kangbeier Child Surgical Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Dukal Corporation Level 1 Pediatric Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Child Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    The iMask Child's Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Prestige Ameritech Pediatric/Child’s Face mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Primed Medical Products, Inc.

    K Number Device Name
    K252964 PRIMED Surgical and Procedure Masks
    K242208 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
    K240286 PRIMED Surgical Masks and PRIMED Procedure Masks
    K233777 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
    K160361 PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
    K092012 PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70
    K081633 PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS