510(k) · Cleared
ClearedGE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · GXY Electrode, Cutaneous
Cleared on Dec 21, 2007 as substantially equivalent to K023459 (Datex-Ohmeda, 2003) and 1 other predicate after a 477-day review. Its family tree reaches back 6 generations to 1977. 4 later devices descend from it.
- Decided
- Dec 21, 2007
- Review
- 477 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K761301 (1977). 10 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK761301 V-Trace Ecg BackpadNdm Corp. · 1977
- 5 generations backK961821 Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc. · 1996
- 4 generations backK994330 Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc. · 2000
- 3 generations backK013389 Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002
- 2 generations backK023459 Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003
- 1 generation backK050835 Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005
- This deviceK062580 GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare · 2007
- Descendant · cites it directly · 1 of its ownK220448 Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK082540 GE Entropy SensorGE Healthcare · 2008
- Descendant · 2 generations on · 0 of its ownK240668 Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK103129 Entropy Easyfit SensorGE Healthcare · 2011
Most influential descendants
Showing 4 of 4 · See all- K220448Disposable Non-invasive EEG SensorShenzhen Med-Link Electronics Tech Co., Ltd. · 2023 · cites it directly1descendant
- K082540GE Entropy SensorGE Healthcare · 2008 · cites it directly1descendant
- K240668Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd. · 2024 · 2 generations on0descendants
- K103129Entropy Easyfit SensorGE Healthcare · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K761301 | V-Trace Ecg Backpad | Ndm Corp. | 1977 | — |
| −5 | K961821 | Aspect Medical Systems Zipprep Eeg Sensor | Aspect Medical Systems, Inc. | 1996 | — |
| −4 | K994330 | Aspect Medical Systems Eeg Sensor, Model 186-0076 | Aspect Medical Systems, Inc. | 2000 | — |
| −3 | K013389 | Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories | Datex-Ohmeda | 2002 | — |
| −2 | K023459 | Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories | Datex-Ohmeda | 2003 | — |
| −1 | K050835 | Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories | GE Healthcare | 2005 | — |
| 0 (this device) | K062580 | GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784) | GE Healthcare | 2007 | — |
| +1 | K220448 | Disposable Non-invasive EEG Sensor | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2023 | — |
| +1 | K082540 | GE Entropy Sensor | GE Healthcare | 2008 | — |
| +2 | K240668 | Amydi-med Disposable Non-invasive EEG electrodes | Shenzhen Amydi-Med Electrics Tech Co., Ltd. | 2024 | — |
| +2 | K103129 | Entropy Easyfit Sensor | GE Healthcare | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K023459 | Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesSummary page 1…stantially equivalent in safety and effectiveness to the predicate Datex-Ohmeda Entropy Sensor cleared with the M-Entropy/E- Entropy modules and accessories submissions (K023459 and K050835). The reusable GE Entropy Cable (REF M1050784) is substantially equivalent in safety and effectiveness to the predica… | 2003 |
| * | K050835 | Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesSummary page 1…quivalent in safety and effectiveness to the predicate Datex-Ohmeda Entropy Sensor cleared with the M-Entropy/E- Entropy modules and accessories submissions (K023459 and K050835). The reusable GE Entropy Cable (REF M1050784) is substantially equivalent in safety and effectiveness to the predicate Datex-Ohm… | 2005 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 30 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K220448 (Shenzhen Med-Link Electronics Tech Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K023459.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
This GE Entropy Sensor is intended to be used for adults with GE Entropy measurement devices to enable recording of physiological signals (such as EEG). To connect this sensor to the measurement device, use the GE Entropy Cable
Use the sensor cable only with GE Entropy measurement devices together with GE Entropy Sensor or Entropy Sensor
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062580 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062580: GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062580
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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