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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: GWM FDA class 2

    Device, Monitoring, Intracranial Pressure

    Neurology

    View full classification →

    The Device, Monitoring, Intracranial Pressure is a neurological monitoring instrument used to continuously measure and record intracranial pressure (ICP), a critical parameter in managing patients with traumatic brain injury, stroke, hydrocephalus, and other neurological conditions. It is an FDA Class 2 device, indicating moderate risk and requiring 510(k) premarket notification. Regulated under 21 CFR 882.1620 with product code GWM in the Neurology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
    CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
    B4C System
    CereLink ICP Monitor
    Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
    Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
    Becker External Drainage and Monitoring System
    BcSs-PICNI-2000 Sensor
    CereLink ICP Monitor, CereLink ICP Extension Cable
    AURA ICP MONITORING SYSTEM
    CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
    MPR2 logO DATALOGGER
    Pressio 2 ICP Monitoring System
    HICP200 Patient/Monitor Interconnect Cable
    Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit
    DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
    QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
    INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
    RAUMEDIC-PTO-MONITORING-SYSTEM
    INTEGRA LICOX PTO2 MONITOR
    INTEGRA CAMINO ICP MONITOR
    INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
    HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
    RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
    RAUMEDIC ICP MONITORING SYSTEM
    RAUMEDIC- ICP-MONITORING SYSTEM
    MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
    CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C
    SENSOMETRICS SOFTWARE
    SYNERGY
    MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
    MPS OXIPORT AND MPS OXIPORT PLUS
    MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
    PRESSIO ICP MONITORING SYSTEM
    INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
    LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
    CMA CEREBRAL TISSUE MONITORING SYSTEM
    NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
    NEUROSYSTEMS 1TM MONITOR
    NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
    MPS (OR MPS-T)
    CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
    LICOX PMO BRAIN MONITORING SYSTEM
    HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
    CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
    NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
    CMA CEREBRAL TISSUE MONITORING SYSTEM
    ACT III VENTRICULAR CATHETER
    CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L
    TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP

    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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