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

    Puritan PurSafe Plus Collection and Transport System

    K Number: K242820 · Decision May 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    16
    Applicant Total
    7
    Review Days
    251

    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
    Puritan PurSafe Plus Collection and Transport System
    K Number
    K242820
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2950
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Puritan Medical Products, LLC
    Date Received
    September 18, 2024
    Decision Date
    May 27, 2025
    Product Code
    QBD
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QBD Microbial Nucleic Acid Storage And Stabilization Device

    Similar 510(k) Clearances

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

    PPH Saliva Collection Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Sample Preservative Fluid

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Molecular Transport Media - MTM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    InActiv Blue

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Sample preservation solution

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DNA/RNA Shield SafeCollect Saliva Collection kit

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

    Other Clearances by Puritan Medical Products, LLC

    K Number Device Name
    K162284 Puritan Fecal Opti-Swab Collection and Transport System
    K160082 Puritan Opti-Tranz Cary-Blair Collection and Transport System
    K142366 Puritan OptiTranz Liquid Stuart Collection and Transport System
    K131630 PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
    K120846 TRANSPORT CULTURE MEDIUM DEVICE
    K113249 TRANSPORT CULTURE MEDIUM DEVICE