510(k) Report

Devices descending from K000865

20 later devices reach Quik-Cap through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112319Electro-Cap SystemElectro-Cap Intl., Inc.201216—
+1K071446Electrode Array CapElectrode Arrays200819—
+2K243243Delphi MCS Electrode CapQuantalx Neuroscience, Ltd.20250—
+2K211315Comby EEG CapsPamel D.O.O20210—
+2K200162Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)Wuhan Greentek Pty, Ltd.20209—
+2K171669g.Nautilus PROG.Tec Medical Engineering GmbH20172—
+2K162460WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode ContactsWavi Co.20171—
+2K110223Waveguard (TM) Eeg CapEemagine Medical Imaging Solutions GmbH201118—
+3K240575WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)Eemagine Medical Imaging Solutions GmbH20240—
+3K223086Ceribell Instant EEG HeadcapCeribell, Inc.20233—
+3K210805Ceribell Instant EEG HeadbandCeribell, Inc.20215—
+3K203331Quick-20mCgx, LLC20211—
+3K202913NeuroCap (Model DEC22)Memory MD, Inc.20210—
+4K254033Ceribell Instant EEG HeadsetCeribell, Inc.20261—
+4K251381Ceribell Instant EEG Headcap (Small: C251, Medium: C252)Ceribell, Inc.20250—
+4K242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20240—
+4K232210X-trodes System MX-Trodes20240—
+4K232052Ceribell Instant EEG HeadbandCeribell, Inc.20233—
+5K260363Ceribell Brain Monitor HeadbandCeribell, Inc.20260—
+5K251936Ceribell Delirium Monitor SystemCeribell, Inc.20250—