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Neurology FDA 510(k) clearances, last 90 days

US companies with an FDA 510(k) clearance in Neurology from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.

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Last 90 days

22 clearances in the last 90 days. The same 90 days a year earlier: 30.

For contract manufacturers and test labs

Neurology accounts for 22 US 510(k) clearances in the last 90 days. The product code with the most clearances in this window is NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes). Contract manufacturers and test labs that work on Neurology devices can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.

Top product codes

Product codeDevice typeClearances
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes3
OBPTranscranial Magnetic Stimulator3
OLTNon-Normalizing Quantitative Electroencephalograph Software2
GWOPlate, Cranioplasty, Preformed, Alterable1
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)1
22 clearances, Aug 2, 2026 to Oct 30, 2026.
Decision dateCompanyDeviceFDA record
Oct 26, 2026Medivis, Inc.NeuroAlignK261997
Oct 26, 2026Foreo, Inc.FAQ™ (FAQ 401);FAQ™ (FAQ 402)K261625
Oct 22, 2026Foreo, Inc.FAQ™ (FAQ 411)K261565
Oct 18, 2026Sway Medical, Inc.Sway System (Sports Plus)K262000
Oct 16, 2026THINK Surgical, Inc.TMINI Miniature Robotic SystemK263234
Oct 9, 2026Neurotronics, LLCSleep Analysis ModuleK261521
Oct 2, 2026Argus Cognitive, Inc.NeuroraK260064
Oct 2, 2026Aesculap, Inc.Ventricular Catheters, Thomale CatheterK260044
Sep 17, 2026SurGenTec, LLCDurashield Device KitK252995
Sep 16, 2026Ceribell, Inc.Ceribell EEG Analysis SoftwareK261712
Sep 11, 2026CraniUS, LLCCraniUS PlateK262874
Sep 11, 2026Xtreem Pulse, LLCPureLift Pro MaxK262861
Sep 6, 2026Fidelity BioPharma Co.KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)K260396
Sep 4, 2026Medtronic Xomed, Inc.ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)K262235
Aug 26, 2026Bioventus, LLCStimTrial Neuromodulation SystemK253877
Aug 25, 2026Beacon Biosignals, Inc.Report StudioK261747
Aug 23, 2026BTL Industries, Inc.BTL-699K260691
Aug 19, 2026Pascall Systems, Inc.Pascall Sensor Unit (PSU1)K254213
Aug 16, 2026FIND Surgical Sciences Inc. D/B/A FIND NeuroCN-Suite™K260563
Aug 14, 2026Cerenovus, Inc.MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MFK262419
Aug 14, 2026Brain Ultimate, Inc.QuickVision Ultimate rTMSK261228
Aug 13, 2026Covidien LPBIS™ Advance pEEG ModuleK260907
  • Oct 26, 2026
    Medivis, Inc.

    NeuroAlign

    K261997
  • Oct 26, 2026
    Foreo, Inc.

    FAQ™ (FAQ 401);FAQ™ (FAQ 402)

    K261625
  • Oct 22, 2026
    Foreo, Inc.

    FAQ™ (FAQ 411)

    K261565
  • Oct 18, 2026
    Sway Medical, Inc.

    Sway System (Sports Plus)

    K262000
  • Oct 16, 2026
    THINK Surgical, Inc.

    TMINI Miniature Robotic System

    K263234
  • Oct 9, 2026
    Neurotronics, LLC

    Sleep Analysis Module

    K261521
  • Oct 2, 2026
    Argus Cognitive, Inc.

    Neurora

    K260064
  • Oct 2, 2026
    Aesculap, Inc.

    Ventricular Catheters, Thomale Catheter

    K260044
  • Sep 17, 2026
    SurGenTec, LLC

    Durashield Device Kit

    K252995
  • Sep 16, 2026
    Ceribell, Inc.

    Ceribell EEG Analysis Software

    K261712
  • Sep 11, 2026
    CraniUS, LLC

    CraniUS Plate

    K262874
  • Sep 11, 2026
    Xtreem Pulse, LLC

    PureLift Pro Max

    K262861
  • Sep 6, 2026
    Fidelity BioPharma Co.

    KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)

    K260396
  • Sep 4, 2026
    Medtronic Xomed, Inc.

    ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)

    K262235
  • Aug 26, 2026
    Bioventus, LLC

    StimTrial Neuromodulation System

    K253877
  • Aug 25, 2026
    Beacon Biosignals, Inc.

    Report Studio

    K261747
  • Aug 23, 2026
    BTL Industries, Inc.

    BTL-699

    K260691
  • Aug 19, 2026
    Pascall Systems, Inc.

    Pascall Sensor Unit (PSU1)

    K254213
  • Aug 16, 2026
    FIND Surgical Sciences Inc. D/B/A FIND Neuro

    CN-Suite™

    K260563
  • Aug 14, 2026
    Cerenovus, Inc.

    MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF

    K262419
  • Aug 14, 2026
    Brain Ultimate, Inc.

    QuickVision Ultimate rTMS

    K261228
  • Aug 13, 2026
    Covidien LP

    BIS™ Advance pEEG Module

    K260907

Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.

FAQ

Is a 510(k) an FDA approval?
No. The FDA clears a device through a 510(k) when it finds the device substantially equivalent to one already sold in the US.
Where do these rows come from?
From openFDA's 510(k) records, for K numbers Whimbrel already holds. Each K number links to the FDA 510(k) database.
Why do some review panels have no page?
A review panel page is published when the last 90 days have 10 or more US clearances in that panel.

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