510(k) · Cleared
ClearedGE Entropy Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · GXY Electrode, Cutaneous
Cleared on Nov 28, 2008 as substantially equivalent to K062580 (GE Healthcare, 2007) after an 87-day review. Its family tree reaches back 7 generations to 1977. 1 later device descends from it.
- Decided
- Nov 28, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K761301 (1977). 11 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 deviceK082540 GE Entropy SensorGE Healthcare · 2008
- Descendant · cites it directly · 0 of its ownK103129 Entropy Easyfit SensorGE Healthcare · 2011
Most influential descendants
Showing 1 of 1 · See all- K103129Entropy Easyfit SensorGE Healthcare · 2011 · 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) | K082540 | GE Entropy Sensor | GE Healthcare | 2008 | — |
| +1 | 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 |
|---|---|---|
| 2011 | 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? (1)
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 |
|---|---|---|---|
| * | K062580 | GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)Summary page 1…posable GE Entropy Sensor (REF M1038681) is substantially equivalent in safety and effectiveness to the predicate GE Fntropy Sensor (REF M1 123614) cleared Dec. 21,2007 (K062580). . Approved 2008-8-6 15:58 EET DST Antti Ylgstalo M1149634 002 PROJ-REPORT, GE Entropy Sensor Premarket Notification Summary… | 2007 |
| † | K061907 | Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories | 2008 |
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 |
|---|---|---|---|
| K103129 | Entropy Easyfit Sensor | 2011 | 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 31 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K103129 (GE Healthcare, 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062580.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 and pediatric patients older than 2 years 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.
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/K082540 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082540: GE Entropy Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082540
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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