BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Promisemed Heel Blood Lancet

    K Number: K221371 · Decision Jun 8, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    157
    Registration Numbers
    157
    Same Product Code
    109
    Applicant Total
    35
    Review Days
    27

    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
    Promisemed Heel Blood Lancet
    K Number
    K221371
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Promisemed Hangzhou Meditech Co., Ltd.
    Date Received
    May 12, 2022
    Decision Date
    June 8, 2022
    Product Code
    FMK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

    Similar 510(k) Clearances

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

    Verifine Safety Lancets

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

    Safety lancet (XXXVII)

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

    Safety Heel Lancet

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

    Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)

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

    safety lancet

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

    Heel Incision Safety Lancet (SteriHeel 2)

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

    Other Clearances by Promisemed Hangzhou Meditech Co., Ltd.

    K Number Device Name
    K261196 Promisemed VeriEcto Automatic Biopsy Needles
    K261045 Verifine Safety Lancets
    K254273 Verisafe Safety Sterile Needles (SSN)
    K250192 Verisafe Safety Retractable Insulin Syringes
    K250961 Blood collection tube holders
    K251138 Promisemed Safety Huber Needles
    K243332 Promisemed Safety Huber Needles
    K243806 Safety Winged Blood Collection Sets
    K240675 Endoscopic Injection Needles
    K242632 Verifine® Pen Needles
    Search all 35 clearances from Promisemed Hangzhou Meditech Co., Ltd. →