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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: BTL FDA class 2

    Ventilator, Emergency, Powered (Resuscitator)

    Anesthesiology

    View full classification →

    The Ventilator, Emergency, Powered (Resuscitator) is an electrically or pneumatically powered device used in emergency situations to provide artificial ventilation to patients who are not breathing adequately, often in prehospital or critical care settings. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BTL, regulated under 21 CFR 868.5925 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
    Oxymag - Transport and Emergency Ventilator
    VORTRAN GO2VENT with PEEP Valve
    MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
    Puffin Lite Infant Resuscitation System
    SafeT T-Piece Resuscitator
    MOVES SLC
    VORTRAN GO2VENT
    O-TWO E700,O-TWO E600,O-TWO E500
    T-PIECE RESUSCITATOR
    MOVES SLC
    LIFEBORNE INFANT RESUSCITATOR
    EMERGENCY PORTABLE VENTILATOR
    AHP 300, EMERGENCY PORTABLE VENTILATOR
    VENTRAIN
    SAVE II, SAVE II BASIC
    PNEUPAC PARAPAC PLUS
    MANUJET III
    RESUSCI FLOW; RESUSCI FLOW 104
    CAREVENT HANDHELD CPAP SYSTEM
    MERCURY MEDICAL T-PIECE RESUSCITATOR
    MOVES
    ISPIRA RESUSCITATION UNIT
    EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
    BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
    MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
    CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
    MASS CASUALTY VENTILATOR, MODEL MCV100
    MACS CPAP SYSTEM
    VAR MONITOR
    PORTABLE VENTILATOR, MODEL EPV-100
    PNEUPAC VR1 AIR MIX
    SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12
    AUTOVENT 4000 WITH CPAP
    AUTOVENT MODEL 4000
    GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
    UNI-VENT MODEL 73X
    CAREVENT ATV+ AND CAREVENT MRI
    CAREVENT CA AND DRA
    PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS
    BABYPAC
    VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
    COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)
    UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
    PARAPAC 200D TRANSPORT, MODEL V200D
    COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
    PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D
    EMT-CPAP
    RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
    MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR

    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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