Atlas FDA

GXY

439 FDA 510(k) clearances · Product code

90 daysmedian time to decision
274 days90th percentile
439clearances measured

FDA profile

Official device name
Electrode, Cutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1320
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 21 · 2022: 34 · 2023: 25 · 2024: 51 · 2025: 59 · 2026: 47
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) (K260578)Ambu A/S2026-07-14
Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array (K261442)Cadwell Industries, Inc.2026-06-26
BioWave BioWraps (K261522)Biowave Corporation2026-06-03
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) (K253237)Elde Medikal Sanayi ve Ticaret Anonim Sirketi2026-05-08
MR Conditional Cup Electrodes (K254183)Technomed Europe2026-05-07
Tutamen Self Adhesive Electrodes (K252439)Dongguan Tutamen Metalwork Co., Ltd.2026-05-01
myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) (K253256)Otto Bock Healthcare Products GmbH2026-04-22
Ceribell Brain Monitor Headband (K260363)Ceribell, Inc.2026-04-03
Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (K260453)Bionit Labs Srl2026-03-12
Ceribell Instant EEG Headset (K254033)Ceribell, Inc.2026-02-09
Ceribell Instant EEG Headcap (Small: C251, Medium: C252) (K251381)Ceribell, Inc.2025-10-31
Electrotherapy Electrodes (K250841)Baisheng Medical Co., Ltd.2025-08-13
IceCap product line (K243788)Bioserenity Medical Devices Group2025-03-13
Delphi MCS Electrode Cap (K243243)Quantalx Neuroscience, Ltd.2025-02-06
Electrode Pad (K241512)Shenzhen Deliduo Medical Technology Co.,Ltd2025-01-15
Wave Electrode (AE02-60); Wave Electrode (AE02-50) (K242326)Bionit Labs Srl2025-01-02
CAIs Sensor (CAIs-001) (K241160)Brainu Co., Ltd.2024-12-13
WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) (K240575)Eemagine Medical Imaging Solutions GmbH2024-11-25
Grass® MR Conditional/CT Cup Electrodes (K242346)Natus Manufacturing Limited2024-08-29
Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01) (K240108)Gymmax Technology Shenzhen Co., Ltd.2024-06-10
Glide (91000-GL-X) (K240884)Infinite Biomedical Technologies, LLC2024-04-15
Amydi-med Disposable Non-invasive EEG electrodes (K240668)Shenzhen Amydi-Med Electrics Tech Co., Ltd.2024-03-19
Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe (K232995)Shenzhen Roundwhale Technology Co. , Ltd.2024-01-11
Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) (K221199)Green Island International Tcm Group Limited2023-12-19
Conductive Silicone Rubber Electrode (K231167)Guangzhou Xinbo Electronic Co., Ltd.2023-08-09
Conductive carbon film electrode (K231164)Guangzhou Xinbo Electronic Co., Ltd.2023-08-09
Ceribell Instant EEG Headband (K232052)Ceribell, Inc.2023-08-08
Starly pad (K221589)Shenzhen Xingyuanli Technology Co., Ltd.2023-03-24
Motive™ Electrode (K230533)Cymedica Orthopedics, Inc.2023-03-22
Ceribell Instant EEG Headcap (K223086)Ceribell, Inc.2023-03-22
DeltaScan Patch (K222671)Prolira B.V.2023-02-02
Garment Electrodes (K222863)Tone-A-Matic International, Inc.2023-02-01
Self-adhesive Electrode (K222252)Shenzhen Roundwhale Technology Co. , Ltd.2023-01-19
Disposable Non-invasive EEG Sensor (K220448)Shenzhen Med-Link Electronics Tech Co., Ltd.2023-01-19
Alpha Control Liner System (ACLS) (K223738)Coapt2023-01-11
EZ-STIK Electrodes (K223775)South Dakota Partners2023-01-03
ControlSeal Electrode (ELSB) (K223605)Coapt2022-12-30
Self-adhesive Electrode (K222453)Guangdong Comytens Medical Technology Co., Ltd.2022-11-04
Dexus Prosthetics System (Model: MSL1, MSR1) (K220002)Zhejiang Qiangnao Technology Co.,Ltd2022-09-09
Disposable EEG cable (K213884)Shenzhen Changke Connect Electronics Co., Ltd.2022-05-06
Self-adhesive Electrode (K213879)Bozhou Rongjian Medical Appliance Co., Ltd.2022-01-05
Wrap Accessory Electrodes (K210383)Hi-Dow International, Inc.2021-11-12
Comby EEG Caps (K211315)Pamel D.O.O2021-11-09
Adhesive Electrodes (K212191)Voncare Medical Device Co., Ltd.2021-10-06
Adhesive Electrode (K210448)Shaoxing Yingtuo Healthcare Co., Ltd.2021-08-31
Ceribell Instant EEG Headband (K210805)Ceribell, Inc.2021-08-30
Metallic Fabric Electrodes (K202636)Guangzhou Xinbo Electronic Co., Ltd.2021-08-16
Electrode Market Disposable Surface Electrodes (K211839)Electrode Market Co., Ltd.2021-07-28
BioWave BioWraps (K203158)Biowave Corporation2021-07-08
Well-Life Garment Electrodes (GM Series) (K200942)Well-Life Healthcare Limited2021-06-01
NeuroCap (Model DEC22) (K202913)Memory MD, Inc.2021-03-05
MR Conditional Sticky Pad Electrode (K203079)Rhythmlink International, LLC2021-02-09
Jiajian Self-Adhesive Electrode (K192568)Wuxi Jiajian Medical Instrument Co., Ltd.2021-02-03
BRAINSTREAM Disposable Deep Cup EEG Electrodes (K200540)Conmed Corporation2020-06-01
Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) (K190118)Guangzhou Xinbo Electronic Co., Ltd.2020-05-13
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) (K200162)Wuhan Greentek Pty , Ltd.2020-04-21
Disposable Gold Cup EEG Electrodes (K192564)Dymedix Diagnostics, Inc.2020-01-21
Myo Plus (K191179)Otto Bock Healthcare Products GmbH2019-09-04
EEG Electrode Template (K191225)Rhythmlink International, LLC2019-08-05
Wrap accessory electrodes (K190617)Hi-Dow International, Inc.2019-07-02
ELECTRODES PAD (K190700)Shenzhen Bestpad Technology Development Co., Ltd.2019-06-14
COMPLETE CONTROL System Gen2 (K191083)Coapt, LLC2019-05-24
Dome Electrode (K190416)Coapt, LLC2019-04-04
DAEHAN Disposable CUP Electrodes (K180232)Daehan Medical Systems Co., Ltd.2019-04-03
SM Electrodes (K183154)Hong Qiangxing (Shenzhen) Electronics Limited2019-03-26
DL Self-adhesive Electrode (K182111)Shaoxing DL Healthcare Co., Ltd.2019-01-17
Espire Elbow Pro, Espire Elbow Hybrid (K182757)College Park Industries, Inc.2018-11-29
DAEHAN Adhesive Surface Electrodes (K180247)Daehan Medical Systems Co., Ltd.2018-11-01
Sense System with IBT Electrodes (K182112)Infinite Biomedical Technologies, LLC2018-10-05
Self-adhesive Electrode (K181234)Dong Guan OU Kang Electronics Co., Ltd.2018-08-07
ZMI Self-Adhesive Electrodes (K180865)Zmi Electronics , Ltd.2018-06-28
Silverwear Silver Pro Garment Device (K171798)Media Plus, LLC2018-06-01
Reusable and Self-Adhesive Electrodes (K180773)Shaoxing Dongzhi Electrical Technology Co., Ltd.2018-05-22
EEG-Now (K180524)Encephalodynamics, Inc.2018-05-18
NeuroCap (K172866)Memory MD, Inc.2018-04-27
XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) (K172887)Guangzhou Xinbo Electronic Co., Ltd.2018-04-19
Element System with IBT Electrodes (K173571)Infinite Biomedical Technologies, LLC2018-03-21
S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D (K173186)Everyway Medical Instruments Co.,Ltd2018-02-28
Electrodes with snap / Electrodes with pigtail (K171722)Shenzhen Konmed Technology Co., Ltd.2018-01-10
Electrodes with silver conductive (K171721)Shenzhen Konmed Technology Co., Ltd.2018-01-05
Ives MR Conditional Cup Electrode (K171102)Ives Egg Solutions2017-12-21
Adhesive Electrodes (K171381)Shenzhen Quality Medical Technology Co.,Ltd2017-12-13
MR Conditional Cup Electrode, MR Conditional Webb Electrode (K172503)Rhythmlink International, LLC2017-12-01
Disposable Snap Electrode (K172703)Embla Systems2017-11-13
Ceribell Instant EEG Headband (K171459)Ceribell, Inc.2017-08-21
Adhesive Electrodes (K170744)Reno Medical , Ltd.2017-05-08
WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts (K162460)Wavi Co.2017-04-28
Complete Control System (K162891)Coapt, LLC2017-04-14
MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 (K163547)Neurovirtual USA, Inc.2017-04-11
FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W (K161282)Medico Electrodes International , Ltd.2016-10-30
TENS Electrodes (K160081)Cathay Manufacturing Corp.2016-10-19
Adhesive Electrodes (K160138)Gmdasz Manufacturing Co., Ltd.2016-08-11
Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes (K153019)Bio Protech, Inc.2016-03-21
Mailuokang Self-adhesive Electrode (K152815)Shenzhen Mailuokang Technology Co., Ltd.2016-03-08
Ennova Self-adhesive Electrode (K152648)Suzhou Ennova Electronics Technology Co.,Ltd2016-02-18
Dr-Ho's Foot Pad Electrode (K151693)Drtv Asia, Ltd.2015-10-09
Neon EEG (K151576)Incereb, Ltd.2015-09-29
Zekang Self-adhesive Electrode (K150971)Jiangsu Zekang Medical Technology Co., Ltd.2015-08-25
Philips Self-Adhesive Electrodes (K151033)Philips Consumer Lifestyle2015-07-28
DISPOSABLE PRE-GELLED SURFACE ELECTRODE (K142159)Rochester Electro Medical, Inc.2015-06-03
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