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: BSZ FDA class 2

    Gas-Machine, Anesthesia

    Anesthesiology

    View full classification →

    The Gas-Machine, Anesthesia is a complex medical device that delivers precise and controlled mixtures of anesthetic gases and oxygen to a patient during surgical procedures, typically integrated with a ventilator and monitoring components. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BSZ, regulated under 21 CFR 868.5160 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)
    Atlan
    Carestation 750/750c
    A8, A9 Anesthesia System
    Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
    A5 Anesthesia System
    A7 Anesthesia System
    Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
    Aisys CS2
    FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
    Carestation 620/650/650C
    A7 Anesthesia System
    Aespire View
    A7 Anesthesia System
    MADM
    DRE VENTURA
    PERSEUS A500
    A9800 ANESTHESIA WORKSTATION
    FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
    GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
    GE DATEX-OHMEDA AVANCE CS2
    INTELLISAVE AX700 ANESTHESIA SYSTEM
    A5 ANESTHESIA DELIVERY SYSTEM
    GE DATEX-OHMEDA AVANCE CS2
    AESPIRE 7900, AESPIRE VIEW
    MCKESSON ANESTHESIA CARE
    SMARTPILOT VIEW MODEL MK04500
    AM-6000 ANESTHESIA MACHINE
    MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
    GE DATEX-OHMEDA AVANCE
    GE DATEX-OHMEDA AISYS
    NAVIGATOR APPLICATIONS SUITE
    MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30
    AS3700 ANESTHSIA DELIVERY SYSTEM
    CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P
    AESPIRE 7900, AESPIRE VIEW
    GE DATEX-OHMEDA S/5 ADU CARESTATION
    NAVIGATOR APPLICATIONS SUITE
    GE DATEX-OHMEDA AISYS
    COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
    FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO
    GE DATEX-OHMEDA AVANCE
    NAVIGATOR APPLICATIONS SUITE
    FABIUS MRI
    NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
    GE DATEX-OHMEDA AISYS
    MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
    NAVIGATOR APPLICATIONS SUITE
    GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
    ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM

    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