LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K241750
    Device Name
    Medifun Safety Lancet ( MSL1 series)
    Manufacturer
    Medifun Corporation
    Date Cleared
    2024-08-15

    (58 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K220370
    Why did this record match?
    Device Name :

    Medifun Safety Lancet ( MSL1 series)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Safety lancet is intended for capillary blood sampling.

    Device Description

    The Medifun Safety Lancet (MSL1 series) is designed to obtain capillary blood samples from the fingertip. The intended users include healthcare personnel, patients, and lay persons. According to the needle and color differences, the safety lancets have 6 models : MSL1-30, MSL1-28, MSL1-26, MSL1-23, MSL1-21, and MSL1-18. The safety lancets consist of the needle seat, main body, release platform, spring, and protective cap. 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. The lancets contain a safety feature. After use, the puncture mechanism retracts, rendering it unusable for a second time.

    AI/ML Overview

    The provided text is a 510(k) summary for the Medifun Safety Lancet (MSL1 series). It details the device's characteristics, its comparison to a predicate device, and the performance data that supports its substantial equivalence.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    ItemAcceptance CriteriaReported Device Performance
    AppearanceConsistent with the drawings. There should be no damage, dirt, or holes and the protective cap must not be pulled open.Meet the requirement
    DimensionConsistent with the drawings.Meet the requirement
    FirmnessThe needle must remain firmly attached to the plastic part of the needle seat.Meet the requirement
    Needle protrusion lengthUse calipers to measure and meet the requirements.Meet the requirement
    Launch performanceIt must be able to fire smoothly, and there should be no abnormal rebound noise after firing.Meet the requirement
    Puncture forceThe needle tip of the needle should have good puncture ability.Meet the requirement
    DisposableThe safety lancet is only allowed to be puncture once, and it becomes invalid and cannot be fired again after it has been punctured.Meet the requirement
    Safety FeatureThe downward firing force
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1