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

    Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)

    K Number: K220475 · Decision Jul 6, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    23
    Applicant Total
    12
    Review Days
    138

    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
    Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)
    K Number
    K220475
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tianjin Huahong Technology Co., Ltd.
    Date Received
    February 18, 2022
    Decision Date
    July 6, 2022
    Product Code
    QRL
    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
    QRL Multiple Use Blood Lancet For Single Patient Use Only

    Similar 510(k) Clearances

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

    Lancing device (HH-XV-T)

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

    MICROLET®NEXT 2 Lancing Device

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

    Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)

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

    Facet Aurora Reusable Lancet Base

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

    Medifun Lancing Device, Model No. LD-E1

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

    Verifine® Ease Lancing Device, Verifine® Lancing Device

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

    Other Clearances by Tianjin Huahong Technology Co., Ltd.

    K Number Device Name
    K260191 Safety lancet (XXXVII)
    K252490 Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
    K253706 Lancing device (HH-XV-T)
    K251694 safety lancet
    K243306 Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)
    K241627 Safety Lancet (XXXV)
    K240806 Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
    K221176 Insulin Pen Needle
    K220370 Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
    K220372 Heel Stick Safety Lancet (HHZ-II, HHZ-III)
    Search all 12 clearances from Tianjin Huahong Technology Co., Ltd. →