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

    ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT

    K Number: K915226 · Decision Jan 12, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    505
    Review Days
    419

    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
    ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
    K Number
    K915226
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5270
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Healthcare Corp
    Date Received
    November 20, 1991
    Decision Date
    January 12, 1993
    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

    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)

    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
    View all

    Other Clearances by Baxter Healthcare Corp

    K Number Device Name
    K190910 PrisMax System Version 2
    K163530 PrisMax Control Unit
    K130531 ULTRAFUSE
    K132734 NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
    K130245 LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
    K123874 INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
    K123868 INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
    K121092 FLOWEASE [SUBCUTANEOUS] INFUSION SET
    K113227 NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
    K111217 ADDITIVE CAP
    Search all 505 clearances from Baxter Healthcare Corp →