GXY · Class II · 21 CFR 882.1320

FDA Product Code GXY: Electrode, Cutaneous

Leading manufacturers include Medtronic Vascular, Ceribell, Inc. and Guangzhou Xinbo Electronic Co., Ltd..

437
Total
437
Cleared
127d
Avg days
1976
Since
Stable submission activity - 17 submissions in the last 2 years
Consistent review times: 144d avg (recent)

FDA 510(k) Cleared Electrode, Cutaneous Devices (Product Code GXY)

437 devices
1–24 of 437
Cleared Jun 03, 2026
BioWave BioWraps
K261522
Biowave Corporation
Neurology · 27d
Cleared May 08, 2026
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
K253237
Elde Medikal Sanayi ve Ticaret Anonim Sirketi
Neurology · 221d
Cleared May 07, 2026
MR Conditional Cup Electrodes
K254183
Technomed Europe
Neurology · 135d
Cleared May 01, 2026
Tutamen Self Adhesive Electrodes
K252439
Dongguan Tutamen Metalwork Co., Ltd.
Neurology · 270d
Cleared Apr 22, 2026
myosmart. (13E522)
K253256
Otto Bock Healthcare Products GmbH
Neurology · 205d
Cleared Apr 03, 2026
Ceribell Brain Monitor Headband
K260363
Ceribell, Inc.
Neurology · 58d
Cleared Mar 12, 2026
Remote Wave Electrode (AE03-50)
K260453
Bionit Labs Srl
Physical Medicine · 29d
Cleared Feb 09, 2026
Ceribell Instant EEG Headset
K254033
Ceribell, Inc.
Neurology · 55d
Cleared Oct 31, 2025
Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
K251381
Ceribell, Inc.
Neurology · 182d
Cleared Aug 13, 2025
Electrotherapy Electrodes
K250841
Baisheng Medical Co., Ltd.
Neurology · 146d
Cleared Mar 13, 2025
IceCap product line
K243788
Bioserenity Medical Devices Group
Neurology · 94d
Cleared Feb 06, 2025
Delphi MCS Electrode Cap
K243243
Quantalx Neuroscience, Ltd.
Neurology · 118d
Cleared Jan 15, 2025
Electrode Pad
K241512
Shenzhen Deliduo Medical Technology Co.,Ltd
Neurology · 231d
Cleared Jan 02, 2025
Wave Electrode (AE02-60)
K242326
Bionit Labs Srl
Neurology · 149d
Cleared Dec 13, 2024
CAIs Sensor (CAIs-001)
K241160
Brainu Co., Ltd.
Neurology · 231d
Cleared Nov 25, 2024
WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
K240575
Eemagine Medical Imaging Solutions GmbH
Neurology · 269d
Cleared Aug 29, 2024
Grass® MR Conditional/CT Cup Electrodes
K242346
Natus Manufacturing Limited
Neurology · 22d
Cleared Jun 10, 2024
Wrap Accessory Electrodes (GMX-ABSBELT01
K240108
Gymmax Technology Shenzhen Co., Ltd.
Physical Medicine · 146d
Cleared Apr 15, 2024
Glide (91000-GL-X)
K240884
Infinite Biomedical Technologies, LLC
Neurology · 14d
Cleared Mar 19, 2024
Amydi-med Disposable Non-invasive EEG electrodes
K240668
Shenzhen Amydi-Med Electrics Tech Co., Ltd.
Neurology · 11d
Cleared Jan 11, 2024
Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005
K232995
Shenzhen Roundwhale Technology Co. , Ltd.
Neurology · 111d
Cleared Dec 19, 2023
Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)
K221199
Green Island International Tcm Group Limited
Neurology · 602d
Cleared Aug 09, 2023
Conductive carbon film electrode
K231164
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 106d
Cleared Aug 09, 2023
Conductive Silicone Rubber Electrode
K231167
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 106d

About Product Code GXY - Regulatory Context

510(k) Submission Activity

437 total 510(k) submissions under product code GXY since 1976, with 437 receiving FDA clearance (average review time: 127 days).

Submission volume has remained relatively stable over the observed period, with 17 submissions in the last 24 months.

FDA 510(k) Review Time - GXY Product Code

FDA review times for GXY submissions have been consistent, averaging 144 days recently vs 127 days historically.

GXY devices are reviewed by the Neurology panel. Browse all Neurology devices →