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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: BTM FDA class 2

    Ventilator, Emergency, Manual (Resuscitator)

    Anesthesiology

    View full classification →

    The Ventilator, Emergency, Manual (Resuscitator) is a manually operated bag-valve-mask device used to deliver positive pressure ventilation to patients who require respiratory assistance in emergency or resuscitation situations. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BTM, regulated under 21 CFR 868.5915 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting and is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    butterflyBVM
    EOlife®
    Sotair Device
    Disposable Manual Resuscitator
    Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
    Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
    Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
    NEONATALIE RESUSCITATOR
    BABI PLUS NEONATAL RESUSCITATION BAG
    AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
    NEOPOP INFANT RESUSCITATOR WITH FLOW METER
    REVIVATOR
    POCKET BVM
    DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE
    SAVE RESUSCITATOR
    RESUSCITATION TIMER, MODEL L770-CPR
    NEOPIP INFANT RESUSCITATOR
    GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
    RESUSCITATION TIMER, MODEL L770-CPR
    HSINER RESUSCITATOR
    AMBU MARK IV RESUSCITATOR
    AMBU MARK IV BABY RESUSCITATOR
    PVC AND SILICONE MANUAL RESUSCITATORS
    SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
    AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
    AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
    STURDY MANUAL RESUSCITATOR
    MERLIN RESUSCITATOR
    BAWMED E-Z BAG RESUSCITATOR
    VADI MANUAL RESUSCITATOR
    SMART BAG MO
    1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
    NELLCOR INDGO MANUAL RESUSCITATOR
    OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR
    SIMPLIFY COMPACT RESUSCITATOR
    PMX COMPACT RESUCITATOR
    ACUTEVENTILATOR
    PMX DISPOSABLE BAG MASK RESUSCITATOR
    OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR
    1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
    V*CARE MANUAL RESUSCITATOR
    Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
    HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
    AMBU NEONATE SILICONE RESUSCITATOR
    RUSCH MANUAL RESUSCITATOR BAG
    1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
    IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
    MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
    MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
    MANUAL RESUSCITATOR WITH ACE

    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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