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: BZK FDA class 2

    Spirometer, Monitoring (W/Wo Alarm)

    Anesthesiology

    View full classification →

    The Spirometer, Monitoring (W/Wo Alarm) is a device used during mechanical ventilation to continuously measure exhaled tidal and minute volumes, often equipped with alarms to alert clinicians to changes in the patient's ventilatory status. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BZK, regulated under 21 CFR 868.1850 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BEACON Caresystem Model 00002144
    ExSpiron 2Xi
    Gas Module 3
    ExSpiron 1Xi
    ExSpiron 1Xi
    EXSPIRON 1XI
    EXSPIRON
    PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
    WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
    MERCURY VCO2
    PHILIPS NM3 MONITOR, MODEL 7900
    MERCURY VCO2 MODULE WITH CAPNOSTAT 5
    GAS MODULE SE, MODEL 0998-00-0481-02
    CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
    STARTRACK INFANT GRAPHICS MONITOR
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
    CAPNOMAC ULTIMA ANESTHESIA MONITOR
    NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR
    BICORE SMARTVALVE OCCLUSION VALVE
    MODEL 295 ELECTRONIC RESPIROMETER
    NEONATAL METASCOPE
    PARTNER VOLUME MONITOR
    MODEL 1010, CY-MET
    CAV 3.0C SOFTWARE PROGRAM
    RESPITRAK
    MONAGHAN RVM, MODEL 761
    MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
    BEAR NVM-1
    RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL
    RESPIRADYNE II(TM)
    RESPICENTRAL(TM)
    OHMEDA 5410 VOLUME MONITOR
    OHMEDA 5420 VOLUME MONITOR
    RESPIGRAPH
    BEAR NICU-1
    RESPITRACE 300SC
    OHMEDA RM311 RESPIROMETER
    OHMEDA RM121 RESPIROMETER
    RICO RESPIRATION MONITOR
    MEDISHIELD PVM RESPIROMETER
    RESPITRACE 300SC
    RESPICOMB
    OHIO 5400 VOLUME MONITOR
    PORTABLE MONITORING & SCREENING SPIROM.
    SPIROMED RESPIROMETER
    POCKET SPIROMETER
    RESPITRACE SYSTEM
    COMPUTERIZED SPIROMETRY SYSTEM
    MAGTARAK RESPIRATORY MONITOR & FLOW SENS
    BEAR VM-90 VENTILATION 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.

    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