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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: BZQ FDA class 2

    Monitor, Breathing Frequency

    Anesthesiology

    View full classification →

    The Monitor, Breathing Frequency is a device that continuously measures and displays a patient's respiratory rate, providing clinicians with real-time data on breathing patterns to detect abnormalities such as apnea or tachypnea. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BZQ, regulated under 21 CFR 868.2375 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    RTM Sense (A-0001)
    FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
    Philips VSC-MEDlib
    Makani Science™ Respiration Monitoring System
    Airmod
    Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
    Respiree Cardio-Respiratory Monitor
    Dozee VS
    Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
    RespiraSense
    Breathe Easy Mobile Respiratory Monitor (MRM)
    Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
    The C100 Contactless Breathing Monitor
    Linshom Respiratory Monitoring Device (LRMD)
    The RHEA Vital Sign Vigilance System
    Masimo Acoustic Respiration Sensors, infant and neonate
    Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
    EarlySense Bed Sensing Unit
    EarlySense Insight Sytem
    Thora-3Di, Model T-01
    CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM
    INTELLIVUE CL RESPIRATION POD
    NEUROVISION MEDICAL MOTION SENSOR
    EARLYSENSE
    NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO
    EARLYSENSE (EVERON) SYSTEM
    COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
    SLEEPMINDER BREATHING FREQUENCY INDICATOR
    KAI SPOT MODEL KMS 200
    EVERON 1.0
    PNEUMOTHERML, MODEL: 5800
    KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100
    EVERON
    SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR
    EARLYSENSE ES-16 SYSTEM
    GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
    ANDROFLOW - RESPIRATORY RATE MONITOR
    DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100
    OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)
    ULTIMA SMARTBELT, MODEL 0560
    RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S
    GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
    GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
    OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700
    ULTIMA AIRFLOW PRESSURE SENSOR
    ULTIMA AIRFLOW SENSOR, 0510
    BROWSER (EVENT SOFTWARE) MODEL # 4500E
    ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
    ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
    MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR

    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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