BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LMA Fastrach ETT SU

    K Number: K242495 · Decision Apr 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    39
    Review Days
    250

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LMA Fastrach ETT SU
    K Number
    K242495
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Teleflex Medical
    Date Received
    August 22, 2024
    Decision Date
    April 29, 2025
    Product Code
    BTR
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTR Tube, Tracheal (W/Wo Connector)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BTR), ordered by most recent decision date.

    Spiro-VISTA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AeroJet Ventilation Catheter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Teleflex Medical

    K Number Device Name
    K251054 Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
    K243553 QuikClot Control+ Hemostatic Device
    K241784 Arrow® Nitinol Wire
    K233713 Pilling Tracheostomy Tubes
    K232970 Hem-o-lok® Ligating Clips
    K230603 Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
    K231924 EZ-IO Intraosseous Vascular Access System
    K230480 Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
    K222279 Rusch Intermittent Urethral Catheters
    K202492 EZ-IO Intraosseous Vascular Access System
    Search all 39 clearances from Teleflex Medical →