Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GXY — Predicate Candidate Screening
439 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
274 days90th percentile
439clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, | Ambu A/S | 2026-07-14 | 144 | 0 |
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reu | Cadwell Industries, Inc. | 2026-06-26 | 57 | 0 |
| K261522 | BioWave BioWraps | Biowave Corporation | 2026-06-03 | 27 | 0 |
| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 2026-05-08 | 221 | 0 |
| K254183 | MR Conditional Cup Electrodes | Technomed Europe | 2026-05-07 | 135 | 0 |
| K252439 | Tutamen Self Adhesive Electrodes | Dongguan Tutamen Metalwork Co., Ltd. | 2026-05-01 | 270 | 0 |
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. ( | Otto Bock Healthcare Products GmbH | 2026-04-22 | 205 | 0 |
| K260363 | Ceribell Brain Monitor Headband | Ceribell, Inc. | 2026-04-03 | 58 | 0 |
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03 | Bionit Labs Srl | 2026-03-12 | 29 | 0 |
| K254033 | Ceribell Instant EEG Headset | Ceribell, Inc. | 2026-02-09 | 55 | 0 |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. | 2025-10-31 | 182 | 0 |
| K250841 | Electrotherapy Electrodes | Baisheng Medical Co., Ltd. | 2025-08-13 | 146 | 0 |
| K243788 | IceCap product line | Bioserenity Medical Devices Group | 2025-03-13 | 94 | 0 |
| K243243 | Delphi MCS Electrode Cap | Quantalx Neuroscience, Ltd. | 2025-02-06 | 118 | 0 |
| K241512 | Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd | 2025-01-15 | 231 | 0 |
| K242326 | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs Srl | 2025-01-02 | 149 | 0 |
| K241160 | CAIs Sensor (CAIs-001) | Brainu Co., Ltd. | 2024-12-13 | 231 | 0 |
| K240575 | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-27 | Eemagine Medical Imaging Solutions GmbH | 2024-11-25 | 269 | 0 |
| K242346 | Grass® MR Conditional/CT Cup Electrodes | Natus Manufacturing Limited | 2024-08-29 | 22 | 0 |
| K240108 | Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX | Gymmax Technology Shenzhen Co., Ltd. | 2024-06-10 | 146 | 0 |
| K240884 | Glide (91000-GL-X) | Infinite Biomedical Technologies, LLC | 2024-04-15 | 14 | 0 |
| K240668 | Amydi-med Disposable Non-invasive EEG electrodes | Shenzhen Amydi-Med Electrics Tech Co., Ltd. | 2024-03-19 | 11 | 0 |
| K232995 | Neurological Therapy Devices - Accessories: Electrotherapy d | Shenzhen Roundwhale Technology Co. , Ltd. | 2024-01-11 | 111 | 0 |
| K221199 | Conductive Silicone Electrode (model: Foot Pad Electrode, Cu | Green Island International Tcm Group Limited | 2023-12-19 | 602 | 0 |
| K231167 | Conductive Silicone Rubber Electrode | Guangzhou Xinbo Electronic Co., Ltd. | 2023-08-09 | 106 | 0 |
| K231164 | Conductive carbon film electrode | Guangzhou Xinbo Electronic Co., Ltd. | 2023-08-09 | 106 | 0 |
| K232052 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2023-08-08 | 29 | 0 |
| K221589 | Starly pad | Shenzhen Xingyuanli Technology Co., Ltd. | 2023-03-24 | 296 | 0 |
| K230533 | Motive™ Electrode | Cymedica Orthopedics, Inc. | 2023-03-22 | 23 | 0 |
| K223086 | Ceribell Instant EEG Headcap | Ceribell, Inc. | 2023-03-22 | 173 | 0 |
| K222671 | DeltaScan Patch | Prolira B.V. | 2023-02-02 | 149 | 0 |
| K222863 | Garment Electrodes | Tone-A-Matic International, Inc. | 2023-02-01 | 132 | 0 |
| K222252 | Self-adhesive Electrode | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-01-19 | 176 | 0 |
| K220448 | Disposable Non-invasive EEG Sensor | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2023-01-19 | 337 | 0 |
| K223738 | Alpha Control Liner System (ACLS) | Coapt | 2023-01-11 | 28 | 0 |
| K223775 | EZ-STIK Electrodes | South Dakota Partners | 2023-01-03 | 18 | 0 |
| K223605 | ControlSeal Electrode (ELSB) | Coapt | 2022-12-30 | 28 | 1 |
| K222453 | Self-adhesive Electrode | Guangdong Comytens Medical Technology Co., Ltd. | 2022-11-04 | 81 | 0 |
| K220002 | Dexus Prosthetics System (Model: MSL1, MSR1) | Zhejiang Qiangnao Technology Co.,Ltd | 2022-09-09 | 248 | 0 |
| K213884 | Disposable EEG cable | Shenzhen Changke Connect Electronics Co., Ltd. | 2022-05-06 | 144 | 0 |
| K213879 | Self-adhesive Electrode | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-01-05 | 23 | 0 |
| K210383 | Wrap Accessory Electrodes | Hi-Dow International, Inc. | 2021-11-12 | 276 | 0 |
| K211315 | Comby EEG Caps | Pamel D.O.O | 2021-11-09 | 193 | 0 |
| K212191 | Adhesive Electrodes | Voncare Medical Device Co., Ltd. | 2021-10-06 | 86 | 0 |
| K210448 | Adhesive Electrode | Shaoxing Yingtuo Healthcare Co., Ltd. | 2021-08-31 | 196 | 0 |
| K210805 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2021-08-30 | 166 | 0 |
| K202636 | Metallic Fabric Electrodes | Guangzhou Xinbo Electronic Co., Ltd. | 2021-08-16 | 339 | 0 |
| K211839 | Electrode Market Disposable Surface Electrodes | Electrode Market Co., Ltd. | 2021-07-28 | 44 | 0 |
| K203158 | BioWave BioWraps | Biowave Corporation | 2021-07-08 | 259 | 0 |
| K200942 | Well-Life Garment Electrodes (GM Series) | Well-Life Healthcare Limited | 2021-06-01 | 419 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda