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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?
    Product Code :

    QRK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K244031
    Device Name
    Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
    Manufacturer
    SteriLance Medical (Suzhou) Inc.
    Date Cleared
    2025-02-26

    (58 days)

    Product Code
    QRK
    Regulation Number
    878.4850
    Why did this record match?
    Product Code :

    QRK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Blood Lancet is used for capillary blood sampling.
    Device Description
    Disposable Blood Lancet is a single use, sterile medical device designed to be used for capillary blood sampling. The device comprises a stainless needle encapsulated with a plastic needle body and protective cap, the protective cap is twisted off to expose the needle for use. The device was sterilized by Radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.
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    K Number
    K242622
    Device Name
    Sterile Lancets for Single Use
    Manufacturer
    Ningbo Caremed Medical Products Co., Ltd.
    Date Cleared
    2024-10-28

    (55 days)

    Product Code
    QRK, ORL
    Regulation Number
    878.4850
    Why did this record match?
    Product Code :

    QRK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Lancets for Single Use is intended for capillary blood sampling.
    Device Description
    The Sterile Lancets for Single Use is composed two components: needle and needle holder. Needle holder is plastic part that enclosed the needle. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The lancet is together with a lancing device to puncture the skin to obtain a drop of capillary blood from fingertip or from alternative sites. The shelf-life of the product is 5 years.
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    K Number
    K241810
    Device Name
    MICROLET®NEXT Lancet
    Manufacturer
    Ascensia Diabetes Care US Inc
    Date Cleared
    2024-08-15

    (55 days)

    Product Code
    QRK, ORK, QRL
    Regulation Number
    878.4850
    Why did this record match?
    Product Code :

    QRK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable MICROLET®NEXT Lancet is used for capillary blood collection.
    Device Description
    The disposable MICROLET®NEXT Lancet is used for capillary blood collection. The device comprises of a stainless needle encapsulated with a plastic and protective cap; the protective cap is twisted off to expose the needle for use. The device is sterilized by radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.
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    K Number
    K232330
    Device Name
    Lancing System
    Manufacturer
    Ningbo Medsun Medical Co., Ltd.
    Date Cleared
    2024-01-04

    (154 days)

    Product Code
    QRK, QRL
    Regulation Number
    878.4850
    Why did this record match?
    Product Code :

    QRK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lancet is intended to be used to obtain capillary blood sample for self-monitoring of blood glucose. Lancing Device is used with lancets to draw a capillary blood sample for testing, utilizing small amounts of blood. The Lancing Device is intended for use by a single patient and should not be shared.
    Device Description
    Lance Device have two parts, lancet and lancing device. Lancet is composed of a lancet body, a needle and a protective cap. Lancing device is mainly composed of depth adjustment tip, cap, release button, shield, rear sliding barrel and an ejector. The cover consists of inner cover, cap inner core, rear sliding barrel, inner core, buckle ring and two springs, with 12 depth adjustment gears. The lancet is provided as sterile state and have four model: Model BYY3, Model BYY4, Model BYB and Model BYC. The lancet body of Model BYY3 and Model BYY4 is circular, and the lancet body of Model BYB and Model BYC is flat. The lancing device is provided as non-sterile state and a reusable medical device for use only on a single patient and have four model: Model CX11B1, Model CX11B2, Model CX11C1 and Model CX11C2. Model CX11 Lancing device is divided into CX11B (threaded connection) and CX11C (buckle connection) according to the different connection structures of the cap and body of the lancing device. Model CX11B is divided into CX11B1 (suitable for round lancet) and CX11B2 (suitable for flat lancet) according to the different structure of the lancet. Model CX11C is divided into CX11C1(suitable for round lancet) and CX11C2(suitable for flat lancet) according to the different structures of the lancet. The lancet is sterilized by Gamma ray and for single use,the shelf life is 5 years. The lancing device is provided as non-sterile state,for use only on a single patient. The useful life is 5 years or 6000 times.
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    K Number
    K230712
    Device Name
    SG Lanset I, SG Lancets, Soft Lancets
    Manufacturer
    Sewon Medical Co.
    Date Cleared
    2023-12-06

    (266 days)

    Product Code
    QRK, ORK
    Regulation Number
    878.4850
    Why did this record match?
    Product Code :

    QRK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SG LANSET I, SG LANCETS and SOFT LANCETS are indicated to obtain a capillary blood sample from the side of a fingertip for testing utilizing small amounts of blood.
    Device Description
    The SG LANSET I, SG LANCETS and SOFT LANCETS are a single use, sterilized by gamma radiation, which is a pointed piece of surgical steel encased in plastic, used to puncture the skin on one's finger to get a blood sample. The SG LANSET I, SG LANCETS and SOFT LANCETS can be used anytime and anywhere to obtain a blood sample form diabetic patients to measure their blood sugar level. A cap is included to protect the needle from becoming contaminated with dust, etc. The cap completely seals the needle making it impossible for any foreign material to come in contact with the needle. This ensures safe storage and easy portability. The lancing device used with most blood lancets, offers an adjustable tip with variety depth settings for quick, comfortable and easy blood sampling.
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    K Number
    K230310
    Device Name
    STAT Medical Device Lancing System
    Manufacturer
    STAT Medical Devices
    Date Cleared
    2023-09-08

    (217 days)

    Product Code
    QRK, QRL
    Regulation Number
    878.4850
    Why did this record match?
    Product Code :

    QRK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stat Medical Lancing Device Systems are intended for the hygienic collection of capillary blood for testing purposes from the side of a finger and from alternate site, such as the palm, the upper arm, and the forearm. The Stat Medical Lancing Device Systems are for single patient use in a home setting.
    Device Description
    The Stat Medical Lancing Device Systems consist of two types of lancing devices: ULTIMATE Lancing Device and TRIO Lancing Device. Both are single-person, multiple-use devices made of ABS plastic and SUS304 stainless-steel springs. The ULTIMATE has 8 depth-setting choices, and the TRIO has 5 depth-setting choices and a Lancet Ejector. The systems also consist of two types of representative (generic) lancets: COMFORT THIN Twist-Off Lancets and COMFORT THIN Pull-Off Lancets. Both are sterile, single-person, single use devices made of plastic with a SUS304 stainless-steel needle tip and a protective plastic cover. The ULTIMATE and TRIO Lancing Devices have optional Alternative Site Test (AST) Caps.
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    K Number
    K230759
    Device Name
    SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
    Manufacturer
    Bosungmeditech Co., Ltd.
    Date Cleared
    2023-06-13

    (85 days)

    Product Code
    QRK
    Regulation Number
    878.4850
    Why did this record match?
    Product Code :

    QRK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SafeLan® is sterile, single use device that has been designed for single patient use by lay users in a home. Their intended use is for performing skin punctures on patients for the purpose of obtaining capillary blood samples. SafeLan®-Pro: Use with SafeLan® for capillary blood sampling and the SafeLan®-Pro as the multiple use execution device which the SafeLan® lancet attaches.
    Device Description
    SafeLan® blood lancet is a small medical device used for capillary blood sampling. The SafeLan® is a blood lancet consisting of protective cap, needle protector, spring, lancet, and needle. The main component of blood lancet is the small, sharp objects that are used to prick the skin to obtain a small quantity of blood for testing. SafeLan® has 2 models depending on the diameter of the needle. - SafeLan® 26G: 0.46±0.05mm - SafeLan® 30G: 0.30±0.05mm Lancing device (SafeLan®-Pro) combines with the SafeLan® to operate the needle to prick the skin. SafeLan®-Pro is used with SafeLan® to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. SafeLan® is used with compatible lancing device (SafeLan®-Pro) for capillary blood sampling. Safel an 9-Pro consists of loading handle, operation button, depth adjustment confirmation part. The operating principle of SafeLan®-Pro is driven by force of the simple operating sequence is as follows. 1) Insert the SafeLan® clockwise to the front thread of the SafeLan®-Pro. 2) Pull the needle protector of SafeLan® to remove it. 3) Pull and release the loading handle of SafeLan®-Pro. 4) Press the operation button of SafeLan®-Pro. 5) Remove the used SafeLan® from the SafeLan®-Pro by turning them counterclockwise.
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    K Number
    K222617
    Device Name
    EasyTouch Lancing Device
    Manufacturer
    STAT Medical Devices
    Date Cleared
    2023-03-21

    (203 days)

    Product Code
    QRK, QRL
    Regulation Number
    878.4850
    Why did this record match?
    Product Code :

    QRK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyTouch™ Lancing Device is for use with FreeStyle Lancets to collect capillary blood for testing purposes from the fingertip and from alternate sites, such as the palm, the upper arm, or the forearm. The EasyTouch Lancing Device is for single patient use in a home setting.
    Device Description
    The EasyTouch Lancing Device is used with the FreeStyle Lancet, which was cleared under 510(k) K221433 under the device name Facet 28GUniversal Lancet. The intended use of the EasyTouch Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites. The EasyTouch Lancing Device is made of ABS plastic and SUS304 stainless-steel springs. The EasyTouch Lancing Device has 8 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing device end cap placed back onto the device. The user is able to set the desired depth penetration level by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is removed. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with soap and warm water and allowed to air dry after each use and disinfected per the IFU, as needed. If the patient is testing from a site other than the finger an optional AST Cap may be put onto the device instead of the "standard" lancing device end cap. The EasyTouch Lancing Device has an Alternative Site Test (AST) Cap, which is not sold separately. The AST Cap id only provided with the meter kit alongside the lancing device. The AST Cap allows the user to obtain a blood sample from parts of the body other than the fingers. The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a damp cloth and mild detergent to wipe the outside of the lancing device end cap, followed by wiping dry. The device is disinfected via wiping down with a cloth dampened in a bleach wipes) and allowed to air dry. The Alternate Site Testing (AST) Cap is a single-person multi-use optional plastic accessory for the lancing device. It may be used in place of the original lancing device end cap when a patient is taking a blood sample from a site on the body other than the finger. Proper use of the device requires that the user first verify with their physician and the Instructions for Use of the blood glucose test strips or meter they are using to determine if AST testing is appropriate.
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    K Number
    K223815
    Device Name
    ONE DROP Lancing Device
    Manufacturer
    STAT Medical Devices
    Date Cleared
    2023-02-15

    (57 days)

    Product Code
    QRK, QRL
    Regulation Number
    878.4850
    Why did this record match?
    Product Code :

    QRK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The One Drop Lancing Device is for use with One Drop branded Lancets to collect capillary blood for testing purposes from the fingertip. The One Drop Lancing Device is for single patient use in a home setting.
    Device Description
    The One Drop Lancing Device is used with the One Drop branded Lancet, which was cleared under 510(k) K221383 under the device name MedtFine Blood Lancet. The intended use of the One Drop Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites. The One Drop Lancing Device is made of ABS plastic and aluminum plated with Polycarbonate and SUS304 stainless-steel springs. The One Drop Lancing Device has 5 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing device end cap placed back onto the device. The user is able to set the desired depth penetration level by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is safely removed by using the ejector sleeve feature. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with disinfecting wipes and allowed to air dry after each use and disinfected per the IFU, as needed. The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a disinfecting wipe to wipe the outside of the lancing device end cap, followed by wiping dry. The device is cleaned & disinfected using Super Sani-Cloth Germicidal Disposable Wipes and allowed to air dry.
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