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510(k) Data Aggregation

    K Number
    K251694
    Device Name
    safety lancet
    Manufacturer
    Tianjin Huahong Technology Co., Ltd.
    Date Cleared
    2025-06-26

    (24 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin Huahong Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243306
    Device Name
    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)
    Manufacturer
    Tianjin Huahong Technology Co., Ltd.
    Date Cleared
    2024-11-15

    (25 days)

    Product Code
    QRL, FMK, QRK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin Huahong Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lancet: The lancet is intended for capillary blood sampling. Lancing device: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (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) The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T)
    Device Description
    Lancet: The Lancet (use with lancing device) is a single use, sterile medical device, which is designed for use of micro blood sampling puncture to obtain capillary blood samples from the fingertip. The Lancet is composed three components: needle, main body and protective cap. Main body and protective cap is plastic part that enclosed the needle. The Lancet is intended to be single use and the needle tip is sterilized by Radiation. The shelf-life of the product is 5 years. Lancing Device: Along with a lancet, the lancing device is used to obtain a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM, PC and PS Resin. And the spring is made of carbon steel. The service life of the Lancing Device is 5 years or 5000 times of normal use, whichever comes first. For Model HH-XIII-T, the service life of the Lancing Device is 10 years or 5000 times of normal use, whichever comes first. The Lancing Device is provided non-sterile.
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    K Number
    K241627
    Device Name
    Safety Lancet (XXXV)
    Manufacturer
    Tianjin Huahong Technology Co., Ltd.
    Date Cleared
    2024-06-20

    (14 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin Huahong Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The safety lancet is intended for capillary blood sampling.
    Device Description
    The safety lancet is single use medical device, which is designed to collect capillary blood sample. Model XXXV, the safety lancets consist of needle core, button, housing and spring. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.
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    K Number
    K240806
    Device Name
    Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
    Manufacturer
    Tianjin Huahong Technology Co., Ltd.
    Date Cleared
    2024-05-21

    (57 days)

    Product Code
    FMK, MAN
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin Huahong Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The safety lancet is intended for capillary blood sampling.
    Device Description
    The safety lancet is single use medical device, which is designed to collect capillary blood sample. The intended users include Healthcare personnel, patients and lay persons. According to surface difference or structure, the Safety lancets have 7 models: XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV. XXIX, XXX model have sub model according to surface difference. For Model XXVIII and XXX, the safety lancets consist of needle core, button, housing and spring. For Model XXIX, the safety lancets consist of needle core, button, housing, spring, and Depth adjuster ring. For Model XXXI, the safety lancets consist of needle core, top cover, bottom and spring. For Model XXXII, the safety lancets consist of needle core, top cover, bottom, small lid and spring. For Model XXXIII, the safety lancets consist of needle core, button, housing, inner sleeve and spring. And for Model XXXIV, the safety lancets consist of needle core, button, housing, bottom, Protective cap and spring. The sterile part of the safety lancet is the needle tip.The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.
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    K Number
    K220475
    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)
    Manufacturer
    Tianjin Huahong Technology Co., Ltd.
    Date Cleared
    2022-07-06

    (138 days)

    Product Code
    QRL, QRK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin Huahong Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lancet: Lancet is intended for capillary blood sampling. Lancing Device: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared.
    Device Description
    Lancet: The Lancet (use with lancing device) is a single use, sterile medical device, which is designed for use of micro blood sampling puncture to obtain capillary blood samples from the fingertip. The Lancet is composed three components: needle (made of stainless steel and silicone oil), main body and protective cap (both made of PE, EVA and calcium powder). Main body and protective cap is plastic part that enclosed the needle. The Lancet is intended to be single use and the needle tip is sterilized by Radiation. The shelf-life of the product is 5 years. Lancing Device: Along with a lancet, the lancing device is used to collect a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM and PC Resin. And the spring is made of carbon steel. The service life of lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) is no more than 3000 times or 3 years. The service life of lancing device (HH-XVII-T) is no more than 5000 times or 5 years. The Lancing Device is provided non-sterile.
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    K Number
    K221176
    Device Name
    Insulin Pen Needle
    Manufacturer
    Tianjin Huahong Technology Co., Ltd.
    Date Cleared
    2022-07-01

    (67 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin Huahong Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Insulin Pen Needle (Ordinary Type) is intended for use with pen injector devices for the subcutaneous injection of insulin. The Insulin Pen Needle (Safety Type) is sterile, single-use safety needle intended for use with pen iniector devices for the injection of insulin.
    Device Description
    The proposed devices, Insulin Pen Needle (Ordinary Type) and Insulin Pen Needle (Safety Type) are single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. For the safety type, it is designed with a sharp injury prevention feature to minimize the risk from accidental needles sticks. The proposed device is available in 29G, 30G, 31G, 32G and 33G five different specifications with the needle length available in 4mm, 5mm, 6mm, 10mm and 12mm for Insulin Pen Needle (Ordinary Type) and 4mm, 5mm, and 8mm for Insulin Pen Needle (Safety Type). The product is for single use and provided sterile (Irradiation). The shelf-life of the product is five-years.
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    K Number
    K220370
    Device Name
    Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
    Manufacturer
    Tianjin Huahong Technology Co., Ltd.
    Date Cleared
    2022-05-19

    (99 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin Huahong Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The safety lancet is intended for capillary blood sampling.
    Device Description
    The safety lancet is single use medical device, which is designed to collect capillary blood sample. The intended users include Healthcare personnel, patients and lay persons. According to surface difference or structure, the Safety lancets have 8 models: XIII, XVII, XXI, XXIII, XXIV, XXV, XXVI. XVII model have sub model according to surface difference. For Model XIII, XVII, XXI, XXII, XXV, the safety lancets consist of needle core, button, housing, bottom, spring and protective cap. For Model XXIII, the safety lancets consist of needle core, button, housing, and spring. For Model XXIV, the safety lancets consist of needle core, button, housing, spring and ring, And for Model XXVI, the safety lancets consist of needle core, button, housing, small lid and spring. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10° by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.
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    K Number
    K220372
    Device Name
    Heel Stick Safety Lancet (HHZ-II, HHZ-III)
    Manufacturer
    Tianjin Huahong Technology Co., Ltd.
    Date Cleared
    2022-05-17

    (97 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin Huahong Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Heel Stick Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.
    Device Description
    The heel stick safety lancet is offered in various depth size (0.65mm, 0.85mm, 1.00mm, 1.50mm) and width size (1.50 mm, 1.75mm, 2.50 mm, 2.80 mm). It consists of blade base, blade, which is welded with the blade base, spring, top head, bottom, and pushing button. The top head and bottom are intended to provide physical protection to the blade, and PET blister along with the tyvek paper cover the primary sterile barrier system for the device. The product is individually primarily packaged and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years. Heel stick safety lancet is intended to be used by professionals. The product is intended for prescription (Rx) only.
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    K Number
    K202319
    Device Name
    Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
    Manufacturer
    Tianjin Huahong Technology Co., Ltd.
    Date Cleared
    2021-11-12

    (452 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin Huahong Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Insulin Pen Needle (Ordinary Type) is intended for use with pen injector devices for the subcutaneous injection of insulin. The Insulin Pen Needle (Safety Type) is sterile, single-use safety needle intended for use with pen injector devices for the subcutaneous injection of insulin.
    Device Description
    The proposed devices, Insulin Pen Needle (Ordinary Type) and Insulin Pen Needle (Safety Type) are single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. For the safety type, it is designed with a sharp injury prevention feature to minimize the risk from accidental needles sticks. The proposed device is available in 29G, 30G, 31G, 32G and 33G five different specifications with the needle length available in 4mm, 8mm, 10mm and 12mm for Insulin Pen Needle (Ordinary Type) and 4mm, 5mm, and 8mm for Insulin Pen Needle (Safety Type). The product is for single use and provided sterile (Irradiation). The shelf-life of the product is five-years.
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