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510(k) Data Aggregation

    K Number
    K250016
    Device Name
    droplet® personal lancets
    Manufacturer
    HTL-Strefa S.A.
    Date Cleared
    2025-07-01

    (179 days)

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

    HTL-Strefa S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K220643
    Device Name
    DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets
    Manufacturer
    HTL-Strefa S.A.
    Date Cleared
    2022-07-08

    (126 days)

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

    HTL-Strefa S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile, single use medical devices intended for capillary blood sampling.
    Device Description
    DropSafe/droplet Safety Lancets are sterile, single use medical devices intended for capillary blood sampling. The devices have similar design and are gamma sterilized. DropSafe/droplet Safety Lancets comprise needle or blade and are offered with different gages and lengths (different skin penetration depths after puncture). DropSafe/droplet Safety Lancets are sterile until protective cap is removed. DropSafe/droplet Safety Lancets are push-button activated or activated by pressing the device against the puncture site (contact activation). Regardless of the activation mechanism, the devices are designed to minimize the risk form accidental needle/blade sticks with a used needle/blade by application sharps prevention feature. Following use, the needle/blade retracts into the housing which prevents reuse and accidental sticks. The devices are packed in various quantities in boxes. DropSafe/droplet Safety Lancets share the same technological design and principle of operation. The selected models comprise a needle or a blade. The only differences relate to the shape of the outer housing of the devices and the method of their activation.
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    K Number
    K202340
    Device Name
    Droplet Pen Needle 30G & 33G
    Manufacturer
    HTL-Strefa S.A.
    Date Cleared
    2020-10-15

    (59 days)

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

    HTL-Strefa S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DROPLET® PEN NEEDLES 30G & 33G are intended for use with pen injector devices for the subcutaneous injection of drugs.
    Device Description
    DROPLET® PEN NEEDLES 30G & 33G 4G are sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs. The pen needles are OTC devices. The pen needle assembly consists of a double-ended cannula that is assembled into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient end and the cartridge end of the cannula are lubricated using a silicone -based lubricant for ease of injection and rubber septum penetration. There is an inner needle shield assembled over the patient end of the cannula to protect the needle point from damage and accidental needle sticks. There is also an outer cover. Each pen needle assembly is protected with a peel away seal to provide a sterility barrier.
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    K Number
    K171982
    Device Name
    DROPLET PEN NEEDLE
    Manufacturer
    HTL-STREFA S.A.
    Date Cleared
    2018-03-21

    (264 days)

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

    HTL-STREFA S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Droplet® Pen Needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
    Device Description
    The Droplet® Pen Needles are sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs. Pen needles are used by consumers, caregivers and healthcare professionals. The pen needle assembly consists of a double-ended cannula that is assembled into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient end and the cartridge end of the cannula are lubricated using a silicone based lubricant for ease of injection and rubber septum penetration. There is an inner needle shield assembled over the patient end of the cannula to protect the needle point from damage and accidental needle sticks. There is also an outer cover. Each pen needle assembly is protected with a peel away seal to provide a sterility barrier.
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    K Number
    K170988
    Device Name
    DropSafe Safety Pen Needle
    Manufacturer
    HTL-Strefa S.A.
    Date Cleared
    2017-12-12

    (253 days)

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

    HTL-Strefa S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DropSafe Safety Pen Needles are sterile, single-use safety needles intended for use with pen injector devices for the injection of drugs.
    Device Description
    DropSafe Safety Pen Needles are sterile, single-use safety needles intended for use with pen injector devices for the injection of drugs. DropSafe Safety Pen Needles are OTC devices intended to be used by clinical and non-clinical users. DropSafe Safety Pen Needles are offered in one gage - 31 G and in two lengths: 6mm and 8 mm. DropSafe Safety Pen Needles are gamma sterilized, non-toxic single use devices. The device is designed to minimize the risk from accidental needle sticks with a used needle by application of a sharps injury prevention feature. Following use, the needle is locked out preventing reuse. The shield also serves to hide the needle before and after injection. Each DropSafe safety pen needle is individually packaged in a sealed container. The DropSafe safety pen needle is used by removing the seal and attaching it to the pen injector device to administer a drug subcutaneously. While inserting the needle into the skin at a 90° angle, the slides into the shield. While the slider glides into the shield, the safety feature is activated. Following injection, the slider glides back into its initial position, completely covering the needle where it remains locked. The red safety lock indicator tells the user that the safety lock has been activated. Once the safety pen needle is in the locked mode, it cannot be reused. The safety pen needle is detached from the pen injector device and disposed of into a sharps container. The pen needle assembly consists of a double-ended cannula that is assembled into an injection molded hub using an adhesive. The hub has internal threads which allows it to be screwed onto the pen injector device. This allows the cartridge end of the needle to penetrate through the rubber septum of the cartridge. The patient-end and the cartridge end of the cannula are lubricated using a silicone-based lubricant for ease of injection and rubber septum penetration. An injection molded inner shield is assembled over the patient end of the cannula to prevent needle point damage and accidental needle-sticks. This needle assembly is inserted into a protective injection molded container and sealed with a peel away medical grade paper tab which provides a sterility barrier and tamper evident seal.
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    K Number
    K143437
    Device Name
    Droplet Pen Needles
    Manufacturer
    HTL-STREFA S.A.
    Date Cleared
    2015-06-25

    (206 days)

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

    HTL-STREFA S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Droplet® Pen Needles are intended for use with pen injector device for the subcutaneous injection of insulin.
    Device Description
    The Droplet® Pen Needles are sterile, single use needles designed to be used with commercially available pen-injectors for the subcutaneous injection of insulin. Pen needles are used by consumers, caregivers and healthcare professionals. The pen needle assembly consists of a double-ended cannula that is assembled into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient end and the cartridge end of the cannula are lubricated using a silicone based lubricant for ease of injection and rubber septum penetration. There is an inner needle shield assembled over the patient end of the cannula to protect the needle point from damage and accidental needle sticks. There is also an outer protective container. Each pen needle assembly is protected with a peel away seal to provide a sterility barrier. To use a pen needle, the user needs to remove the seal, remove the outer protective cap and attach it to the pen injector. Then the user removes the inner protective cap to expose the needle and make an injection. Following the injection the user inserts the used pen needle into the outer cap to remove the pen needle from the pen injector and dispose of it immediately. The pen needle is individually packaged and sterilized with Gamma radiation. It is intended for single use only. Droplet® Pen Needles are available in the following lengths and gauges: 4 mm x 32G, 5 mm x 32G, 6 mm x 32G, 8 mm x 32G, 5 mm x 31G, 6 mm x 31G, 8 mm x 31G, 10 mm x 29G, 12 mm x 29G.
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