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    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: BZD FDA class 2

    Ventilator, Non-Continuous (Respirator)

    Anesthesiology

    View full classification →

    The Ventilator, Non-Continuous (Respirator) is a ventilator designed to assist breathing on a non-continuous or intermittent basis, supporting patients with periodic respiratory compromise rather than continuous mechanical ventilation. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BZD, regulated under 21 CFR 868.5905 in the Anesthesiology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    F&P Nova Nasal Mask
    myAir
    WiZARD 520 Full Face Mask
    AirFit F20 Mask System; AirFit F20 NM Mask System
    Respiration Data Management Software (PAP Link PC)
    Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)
    Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask
    EasyCare Tx 2
    myAir
    AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System
    Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA)
    AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask
    Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask
    DELTAWAVE Nasal Pillows System
    iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask
    Oran Park Mask
    Therapy Mask 3100 NC/SP
    Whitsundays Mask System
    F&P 950 Accessory Breathing Circuit Kits
    F&P Solo Mask Range
    Luna G3 BPAP System
    F&P Evora Full Face Mask
    Auto CPAP System
    iQ 2 Nasal Mask, Phantom 2 Nasal Mask
    DreamWear Silicone Pillows Mask
    Magneto Nasal Mask
    Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask
    Innova Nasal Non-Vented Mask
    Luna® G3 BPAP 25A
    Galapogos
    S10 Kirra
    SysMed S/T
    WiZARD 510 Nasal Mask
    Ventilator, Non-continuous (Respirator)
    DreamStation 2 System, DreamStation 2 Advanced System
    F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
    Care Orchestrator Essence
    F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)
    Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
    WiZARD 310/320 Series CPAP Mask
    Moore Park Mask
    Care Orchestrator
    Transcend 365 miniCPAP System
    F&P SleepStyle
    Scone Mask
    Bleep DreamPort
    AirFit F20
    AirFit N20
    Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
    SleepWeaver 3D Nasal Mask

    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.

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