LogoFDA 510(k) Search
Search Filters

Search Results

Found 9903 results

510(k) Data Aggregation

    K Number
    K251177

    Validate with FDA (Live)

    Device Name
    Self-Seal Sterilization Pouch and Roll
    Manufacturer
    Guangdong Maidi Medical Co., Ltd.
    Date Cleared
    2025-12-12

    (240 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K251089

    Validate with FDA (Live)

    Device Name
    EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle
    Manufacturer
    Exelint International, Co.
    Date Cleared
    2025-12-12

    (246 days)

    Product Code
    N/A
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K250847

    Validate with FDA (Live)

    Device Name
    VaporShield
    Manufacturer
    Vault Paragon Group, Inc.
    Date Cleared
    2025-12-12

    (267 days)

    Product Code
    MEG,FMF,FMI,ONB
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K252941

    Validate with FDA (Live)

    Device Name
    HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
    Manufacturer
    O&M Halyard, Inc.
    Date Cleared
    2025-12-11

    (87 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K250192

    Validate with FDA (Live)

    Device Name
    Verisafe Safety Retractable Insulin Syringes
    Manufacturer
    Promisemed Hangzhou Meditech Co., Ltd.
    Date Cleared
    2025-12-10

    (321 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K251722

    Validate with FDA (Live)

    Device Name
    ProSeal™ Transfer Injector (421120, 421130, 421140)
    Manufacturer
    Epic Medical Pte. , Ltd.
    Date Cleared
    2025-12-05

    (184 days)

    Product Code
    ONB
    Regulation Number
    880.5440
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K251257

    Validate with FDA (Live)

    Device Name
    nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
    Manufacturer
    Np Medical
    Date Cleared
    2025-12-04

    (225 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K250564

    Validate with FDA (Live)

    Device Name
    Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
    Manufacturer
    Yadu Medical (Henan) Co., Ltd.
    Date Cleared
    2025-12-03

    (280 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K250884

    Validate with FDA (Live)

    Device Name
    0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
    Manufacturer
    Becton, Dickinson and Company
    Date Cleared
    2025-12-02

    (253 days)

    Product Code
    NGT
    Regulation Number
    880.5200
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K252355

    Validate with FDA (Live)

    Device Name
    K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
    Manufacturer
    Sb-Kawasumi Laboratories, Inc.
    Date Cleared
    2025-11-26

    (120 days)

    Product Code
    PTI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K190233,K060812
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is an intravascular administration set with a non-coring Huber needle used for drug administration and blood sampling through implanted vascular port systems.

    The needle tip is equipped with an anti-needle stick protector to reduce the possibility of accidental needle sticks. This device is also applicable to high-pressure injection with power injectors, when used with a port system indicated for high-pressure injection.

    Device Description

    The K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (here in after K-SHIELD Advantage HP-PAIS) is an intravascular administration set with a non-coring Huber needle used for drug administration and blood sampling through implanted vascular port systems.

    The needle tip is equipped with an anti-needle stick protector to reduce the possibility of accidental needle sticks. This device is also applicable to high-pressure injection with power injectors, when used with a port system indicated for high-pressure injection.

    This device has a Huber needle for insertion into the septum of an implanted port, for infusion and blood sampling through the port. This needle is equipped with wings of a specific shape and rigidity to ensure that the user can securely hold the device during needle insertion and withdrawal. Additionally, the alignment of the gripping position and the puncture point along a straight line supports accurate puncture placement. The device features a safety mechanism that activates upon needle withdrawal, with a safety shield covering the needle tip.

    The activation of the safety mechanism is audibly confirmed by a click sound. Moreover, the device is equipped with high-pressure resistant tubing and clamp, enabling the supply of medications such as contrast media using an automatic injector.

    Specification

    Needle gaugeNeedle lengthTube length (mm)
    19G3/4"w/o Y site: 170
    With Y site: 100/100
    1"w/o Y site: 170
    With Y site: 100/100
    20G3/4"w/o Y site: 170
    With Y site: 100/100
    1"w/o Y site: 170
    With Y site: 100/100
    22G3/4"w/o Y site: 170
    With Y site: 100/100
    1"w/o Y site: 170
    With Y site: 100/100
    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 991