BEUDAMED
    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: BTR FDA class 2

    Tube, Tracheal (W/Wo Connector)

    Anesthesiology

    View full classification →

    The Tube, Tracheal (W/Wo Connector) is a flexible tube inserted through the mouth or nose and advanced into the trachea to secure the airway and enable mechanical ventilation during surgery or critical care. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BTR, regulated under 21 CFR 868.5730 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    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)
    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)
    LMA Fastrach ETT SU
    Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)
    Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
    Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
    Wei Nasal Jet Tube
    Tenax Laser Resistant Endotracheal Tube
    Tenax Laser Resistant Endotracheal Tube
    Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm
    Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff
    Endotracheal Tube with Evacuation Lumen
    Sheridan Spiral-Flex Endotracheal Tubes
    SolidAIRity III Airway Stabilization System
    Yikang Endotracheal Tube
    Endotracheal Tube
    VivaSight-SL (TVT) system
    Frova Intubating Introducer
    NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
    Endotracheal tube; Reinforced Endotracheal tube
    IRRIS (Infra-Red-Red Intubation System)
    Frova Intubating Introducer
    Disposable Endotracheal tube, sterile, AccuCuff
    ETView VivaSight-SL (TVT) system
    Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
    Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
    RHINOGUARD
    DISPOSABLE TRACHEAL TUBE
    TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET
    RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE
    KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
    KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
    BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE
    BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)
    ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))
    KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS
    AMBU ASCOPE 2
    WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
    PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE
    AMBU ASCOPE AND MONITOR
    VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE
    TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT
    EZC MEDICAL, LLC INTUBAIDFLEX
    PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5
    FLEXICARE MEDICAL ENDOTRACHEAL TUBES
    CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
    TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
    ENDOTRACHEAL TUBE
    MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
    TRACHEOSCOPIC VENTILATION TUBE (TVT)

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump