510(k) · Cleared
ClearedDisposable Non-invasive EEG Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Med-Link Electronics Tech Co., Ltd. · GXY Electrode, Cutaneous
Cleared on Jan 19, 2023 as substantially equivalent to K143506 (Covidien, 2015) and 1 other predicate after a 337-day review. Its family tree reaches back 7 generations to 1977. 1 later device descends from it.
- Decided
- Jan 19, 2023
- Review
- 337 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K761301 (1977). 15 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK761301 V-Trace Ecg BackpadNdm Corp. · 1977
- 6 generations backK961821 Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc. · 1996
- 5 generations backK994330 Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc. · 2000
- 4 generations backK013389 Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002
- 3 generations backK023459 Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003
- 2 generations backK050835 Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005
- 1 generation backK062580 GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare · 2007
- This deviceK220448 Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK240668 Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240668Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K761301 | V-Trace Ecg Backpad | Ndm Corp. | 1977 | — |
| −6 | K961821 | Aspect Medical Systems Zipprep Eeg Sensor | Aspect Medical Systems, Inc. | 1996 | — |
| −5 | K994330 | Aspect Medical Systems Eeg Sensor, Model 186-0076 | Aspect Medical Systems, Inc. | 2000 | — |
| −4 | K013389 | Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories | Datex-Ohmeda | 2002 | — |
| −3 | K023459 | Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories | Datex-Ohmeda | 2003 | — |
| −2 | K050835 | Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories | GE Healthcare | 2005 | — |
| −1 | K062580 | GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784) | GE Healthcare | 2007 | — |
| 0 (this device) | K220448 | Disposable Non-invasive EEG Sensor | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2023 | — |
| +1 | K240668 | Amydi-med Disposable Non-invasive EEG electrodes | Shenzhen Amydi-Med Electrics Tech Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GXY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GXY device
- #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K143506 | Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3 Electrodes…Summary page 5…Number Code Covidien Electrode, Medtronic Plc Class II, 21 CFR K143506 BIS Sensors Cutaneous GXY 882.1320 (BIS Quatro Electrode S… | 2015 |
| * | K062580 | GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)Summary page 5…Pediatric Sensor, BIS Bilateral Sensor) GE Entropy Entropy GE Healthcare Class II, 21 CFR K062580 2 Sensor Sensor GXY 882.1320 6. Intended Use and Indications for U… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240668 | Amydi-med Disposable Non-invasive EEG electrodes | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 46 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K240668 (Shenzhen Amydi-Med Electrics Tech Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K143506.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GXY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXY
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXY
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXY
58in 2025
MAUDE reports naming product code GXY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 88 | 0 | 14 |
| 2008 | 9 | 136 | 0 | 17 |
| 2009 | 17 | 159 | 4 | 15 |
| 2010 | 3 | 137 | 1 | 14 |
| 2011 | 6 | 183 | 5 | 16 |
| 2012 | 9 | 150 | 4 | 16 |
| 2013 | 7 | 99 | 0 | 15 |
| 2014 | 9 | 203 | 0 | 11 |
| 2015 | 6 | 119 | 0 | 19 |
| 2016 | 6 | 170 | 0 | 15 |
| 2017 | 9 | 116 | 0 | 11 |
| 2018 | 14 | 135 | 0 | 10 |
| 2019 | 9 | 113 | 0 | 19 |
| 2020 | 4 | 108 | 0 | 11 |
| 2021 | 12 | 195 | 0 | 21 |
| 2022 | 5 | 81 | 0 | 34 |
| 2023 | 13 | 132 | 2 | 25 |
| 2024 | 7 | 111 | 0 | 51 |
| 2025 | 6 | 148 | 0 | 58 |
| 2026 | 12 | 70 | 0 | — |
What is it indicated for?
Disposable Non-invasive EEG Sensor is applied directly to the patient’s skin to enable recordings of electrophysiological (such as EEG) signals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220448: Disposable Non-invasive EEG Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220448
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026