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

    Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)

    K Number: K253322 · Decision Mar 25, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    29
    Review Days
    176

    Basic Information

    Device Name
    Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)
    K Number
    K253322
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5270
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medline Industries, LP
    Date Received
    September 30, 2025
    Decision Date
    March 25, 2026
    Product Code
    BZE
    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
    BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

    Similar 510(k) Clearances

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

    inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Heated Breathing Tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Sunset Heated CPAP Tube

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

    Other Clearances by Medline Industries, LP

    K Number Device Name
    K251687 Konig Bell Circumcision Clamp
    K253070 Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
    K250345 Medline Bag Decanter
    K250312 Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
    K243888 Medline UNITE® REFLEX® Hybrid Nitinol Implant System
    K242844 Medline Level 4 Surgical Gown with Breathable Sleeves
    K241778 Hudson RCI Comfort Flo® CubCannula™
    K242370 Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))
    K240163 Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula
    K234132 Medline Reusable Sterilization Wrappers
    Search all 29 clearances from Medline Industries, LP →