Search Filters

Search Results

Found 138 results

510(k) Data Aggregation

    K Number
    K243207
    Device Name
    BD Vacutainer® Eclipse™ Blood Collection Needle
    Manufacturer
    Becton Dickinson and Company
    Date Cleared
    2025-07-03

    (275 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    JKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K250961
    Device Name
    Blood collection tube holders
    Manufacturer
    Promisemed Hangzhou Meditech Co., Ltd.
    Date Cleared
    2025-06-04

    (65 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    JKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. It is for adult use only.
    Device Description
    Blood collection tube holders is single use and sterile, it is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. It is sterile and to be used for assisting blood collection. The device consists of a puncture needle hub, puncture needle, rubber boot and holder. It is packaged in a sealed sterility barrier. This is a single-use device and delivered sterile. Sterilization process is validated according to EN ISO 11135. Shelf life is 5 years.
    Ask a Question
    K Number
    K244047
    Device Name
    Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
    Manufacturer
    Venocare, Inc.
    Date Cleared
    2025-05-23

    (143 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    JKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Navi™ Needle-free Blood Collection Device attaches to a peripheral intravascular catheter (PIVC) system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.
    Device Description
    The Navi™ Needle-free Blood Collection Device is a sterile packaged single use product designed to be attached to an already placed peripheral intravascular catheter (PIVC) system. The device is comprised of an inner flow tube with an atraumatic tip attached to a plunger that is advanced and retracted with the use of a slider. The slider extends through the proximal end of the housing and is connected to the plunger. A male cannula is positioned at the distal end of the housing with Luer clips configured to connect to a PIVC system. The inner flow tube is intended to be advanced distally through the PIVC into a patient blood vessel establishing fluid communication between the blood vessel and the collection assembly. The inner flow tube is designed to extend beyond the distal end of the PIVC. A lateral flexible tube with a female Luer connected to the housing provides a connection point for an evacuated tube holder or syringe to obtain a blood sample. Once complete, the inner flow tube is fully retracted back into the housing, and the device is removed from the PIVC system. The device is available in three sizes (20 GA, 22 GA and 24 GA) that are compatible with the corresponding PIVC.
    Ask a Question
    K Number
    K250907
    Device Name
    Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
    Manufacturer
    Sol-Millennium Medical, Inc.
    Date Cleared
    2025-04-30

    (35 days)

    Product Code
    JKA, FPA
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    JKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sol-Guard™ XtraThin Wall Safety Pull button blood collection set is a sterile, multi-sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens from patients. When used without the male Luer adaptor, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and should remain under the direct supervision of a clinician. The recommended use of the device is to activate the needle safety feature prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.
    Device Description
    Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term (up to 2 hours) infusion of intravenous fluids. The device is offered with butterfly needle set which has either 21-, 23- or 25-gauge needle with integral butterfly wings, offered in two different flexible tubing lengths of 178mm and 305mm, and a safety tube with tubing leading to a female luer connector. The female luer connector is optionally attached to a luer adapter, or luer adapter plus a tube holder. The device is designed with spring retractable needle technology that allows needle retraction after use to prevent needle stick injury and blood exposure. When the Button on the body of the butterfly is pulled back, the spring is released, and the needle is retracted into the clear plastic safety tube. In the activated position, the needle is completely enclosed within the clear plastic safety tube which guards against accidental needlesticks during normal handling and disposal.
    Ask a Question
    K Number
    K243649
    Device Name
    BD Vacutainer® Multiple Sample Luer Adapter
    Manufacturer
    Becton Dickinson and Company
    Date Cleared
    2025-03-21

    (115 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    JKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BD Vacutainer® Multiple Sample Luer Adapter is a sterile, single-use, non-invasive medical device intended to be connected with BD Vacutainer® brand needle holders, to enable blood collection from venous access devices, such as needles and blood collection sets or catheters with female luer connectors into blood collection tubes or blood culture bottles for the purpose of in vitro diagnostic testing. These devices are intended to be used by healthcare professionals.
    Device Description
    The BD Vacutainer® Multiple Sample Luer Adapter consists of a luer-slip fitting (male) which mates with the female Luer connector of venous access devices, and an NP (non-patient) cannula, which punctures the stopper of the evacuated tube(s), or the septum of a blood culture bottle(s) to collect blood. The NP cannula of the device is lubricated and has a sleeve that recovers over the cannula to prevent leakage during blood collection in-between tubes and/or bottles. Each end of the device is enclosed in a plastic shield, which join together to fully protect the device. A tamper evident label secures the two shields together and allows identification of whether the sterile barrier has been compromised. The device consists of the following components: - Non-patient (NP) Cannula - Sleeve - Luer Hub - NP Shield - IV Shield - Epoxy Note: the IV Shield is intended for maintaining sterility of the luer-slip of the device; there is no IV needle component.
    Ask a Question
    K Number
    K241586
    Device Name
    PIVO™ Pro Needle-free Blood Collection Device
    Manufacturer
    Becton Dickinson Infusion Therapy Systems, Inc.
    Date Cleared
    2025-02-27

    (269 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    JKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube, blood culture bottle, or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. For blood culture, the device can be used at initial placement of the peripheral IV catheter.
    Device Description
    The PIVOTM Pro Needle-free Blood Collection Device is a sterile, single use needle-free collection device that attaches to a peripheral intravascular (IV) catheter system for use to obtain venous blood specimens. The device is comprised of an inner flow tube with a slider, proximal flexible tube with female Luer, outer housing and winged clip on the distal end. The winged clip attaches to the catheter system The female Luer attaches to an evacuated tube holder or syringe. The inner flow tube is then advanced to collect a blood sample. Once complete, the inner flow tube is retracted, and the device is removed from the IV. The device is also suitable for use for blood culture collection at initial placement of peripheral IV catheters. The device is available in three sizes: 20GA, 22GA and 24GA IV compatible. The device is compatible with the corresponding IV gauge and larger IV catheters. The PIVOTM Pro Needle-free Blood Collection Device is compatible with peripheral IV catheters and extension sets with NearPortTM IV Access.
    Ask a Question
    K Number
    K242320
    Device Name
    BD Vacutainer® One Use Holder
    Manufacturer
    Becton Dickinson and Company
    Date Cleared
    2024-11-01

    (88 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    JKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BD Vacutainer® One Use Holder is a single-use, non-sterile device used by healthcare professionals to attach and hold a BD Vacutainer® brand venous access device such as a blood collection needle, a blood collection set, or a luer adapter during venipuncture connected to a BD Vacutainer® blood collection tube(s). This device may also be used with a BD Vacutainer® blood collection set with a luer adapter to obtain blood samples into a BD BACTEC™ blood culture bottle.
    Device Description
    The BD Vacutainer® One Use Holder is a non-sterile, single-use plastic device used during the blood collection process. It consists of a one piece plastic barrel with a female threaded connector at one end into which the non-patient end of the hub of a BD Vacutainer® blood collection device is screwed. The other end is open for the insertion of a BD Vacutainer® evacuated blood collection tube or BD BACTECTM Blood Culture Bottle This end also has flanges, which are intended to assist tube insertion. BD Vacutainer® One Use Holder is used to attach and hold a BD Vacutainer® Brand venous access device such as a blood collection needle, blood collection set or Multiple Sample Luer Adapter during venipuncture and to connect the subject device to a BD Vacutainer® blood collection tube or BD BACTEC™ blood culture bottle.
    Ask a Question
    K Number
    K233979
    Device Name
    VACUETTE® QUICKSHIELD Complete (Plus)
    Manufacturer
    Greiner Bio-One North America Inc
    Date Cleared
    2024-07-19

    (214 days)

    Product Code
    JKA, FMI
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    JKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VACUETTE® QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. They are for single-use only and should be used by properly trained healthcare professionals only in accordance with these instructions. The VACUETTE® QUICKSHIELD Complete PLUS is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. VACUETTE® VISIO PLUS Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single- use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.
    Device Description
    The sterile VACUETTE®QUICKSHIELD Complete is a single packed VACUETTE®QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® Multiple Use Drawing Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture. The sterile VACUETTE® QUICKSHIELD Complete PLUS is a single packed VACUETTE® QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® VISIO PLUS Blood Collection Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture.
    Ask a Question
    K Number
    K232781
    Device Name
    Safety Sliding Blood Collection Set
    Manufacturer
    Jiangsu Caina Medical Co., Ltd.
    Date Cleared
    2024-03-07

    (178 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    JKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Safety Sliding Blood Collection Set is intention into a patient's vascular system for blood collection or short term (up to 2 hours) IV administration, by a trained medical professional. It aids in the prevention of accidental needle stick through the use of an active safety feature.
    Device Description
    Components of the subject device include: (1) Needle cap, (2) Butterfly wings, (3) Safety shield, (4) Needle, (5) Flexible tube, (6) Female luer (adapter), (7) Male luer hub, (8) Puncture needle, (9) Rubber sleeve, (10) Puncture needle protect cover, (11) Holder, (12) Protective cap. The subject device has three configurations: with Holder, with Holder, without Male Adapter. Each configuration has all of the (1) - (6) components mentioned above. The difference between the three configurations is that they have only one or more of the (7) – (12) components mentioned above. The proposed device is available various needle size and flexible tube length. The range of needle size is from 25G (0.5mm) to 20G (0.9mm). The range of flexible tube length is from 10cm (4") to 30cm (12"). The subject device has sharps injury protection features. It aids in the prevention of accidental needle stick through the use of an active safety feature. The subject device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years. No DEHP, BPA and Natural Rubber Latex are added in the proposed device.
    Ask a Question
    K Number
    K231373
    Device Name
    BD Vacutainer® K2 EDTA Blood Collection Tubes
    Manufacturer
    Becton Dickinson and Company
    Date Cleared
    2024-02-02

    (266 days)

    Product Code
    JKA, GIM
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    JKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BD Vacutainer® K2 EDTA Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, containment, preservation, and transport of human venous blood specimens used for in vitro diagnostic testing. BD Vacutainer® K2 EDTA Blood Collection Tubes are used for Hemoglobin A1c (HbA1c) testing.
    Device Description
    BD Vacutainer® K2EDTA Blood Collection Tubes are used for collection, containment, preservation, and transport of human venous blood specimens in a closed tube. The evacuated blood collection tube consists of a Vacutainer® Hemogard™ Closure Assembly, a plastic tube and EDTA additive. The EDTA anticoagulant is spray coated in the dipotassium (K2) form. The EDTA additive prevents specimen coagulation. The plastic tubes are closed with the Vacutainer® Hemogard™ Closure Assembly which consists of a rubber stopper and protective plastic shield. The Hemogard™ Closure Assembly, introduced in 1995, is intended to help reduce user exposure to blood. All stopper/closures are color coded to reflect additive type; the closures included in this submission are lavender to indicate the presence of the EDTA additive. The plastic tube is manufactured from Polyethylene terephthalate (PET). These plastic tubes were introduced in 1990. Plastic tubes enhance user safety and disposal because of the reduced risk of tube breakage and the availability of incineration as a method of disposal.
    Ask a Question

    Page 1 of 14