510(k) · Cleared
ClearedEntropy Easyfit Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · GWQ Full-Montage Standard Electroencephalograph
Cleared on Jul 19, 2011 as substantially equivalent to K082540 (GE Healthcare, 2008) and 1 other predicate after a 270-day review. Its family tree reaches back 8 generations to 1977.
- Decided
- Jul 19, 2011
- Review
- 270 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K761301 (1977). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK761301 V-Trace Ecg BackpadNdm Corp. · 1977
- 7 generations backK961821 Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc. · 1996
- 6 generations backK994330 Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc. · 2000
- 5 generations backK013389 Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002
- 4 generations backK023459 Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003
- 3 generations backK050835 Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005
- 2 generations backK062580 GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)GE Healthcare · 2007
- 1 generation backK082540 GE Entropy SensorGE Healthcare · 2008
- This deviceK103129 Entropy Easyfit SensorGE Healthcare · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K761301 | V-Trace Ecg Backpad | Ndm Corp. | 1977 | — |
| −7 | K961821 | Aspect Medical Systems Zipprep Eeg Sensor | Aspect Medical Systems, Inc. | 1996 | — |
| −6 | K994330 | Aspect Medical Systems Eeg Sensor, Model 186-0076 | Aspect Medical Systems, Inc. | 2000 | — |
| −5 | K013389 | Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories | Datex-Ohmeda | 2002 | — |
| −4 | K023459 | Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories | Datex-Ohmeda | 2003 | — |
| −3 | K050835 | Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories | GE Healthcare | 2005 | — |
| −2 | K062580 | GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784) | GE Healthcare | 2007 | — |
| −1 | K082540 | GE Entropy Sensor | GE Healthcare | 2008 | — |
| 0 (this device) | 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 |
| 2008 | 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 GWQ? 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 GWQ device
- #1 K260455 New Wave Systemscore 13.7 · 10 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 |
|---|---|---|---|
| * | K082540 | GE Entropy SensorSummary page 1…n/Usual Name: Entropy Sensor, Electrode, Cutaneous Classification Names: 882.1400, 882.1320 Product Code: GWQ, GXY Predicate Device(s): K082540 GE Entropy Sensor K061907 Entropy Sensor Device Description: Cutaneous sheet electrode to… | 2008 |
| * | K061907 | Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and AccessoriesSummary page 1…s Classification Names: 882.1400, 882.1320 Product Code: GWQ, GXY Predicate Device(s): K082540 GE Entropy Sensor K061907 Entropy Sensor Device Description: Cutaneous sheet electrode to be used with GE Entropy m… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 13 ancestors has a recall.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GWQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWQ
137in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWQ
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWQ
13in 2025
MAUDE reports naming product code GWQ, 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 | 1 | — | 5 | 11 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 0 | — | 1 | 7 |
| 2010 | 3 | 73 | 1 | 12 |
| 2011 | 4 | 220 | 0 | 6 |
| 2012 | 4 | 208 | 0 | 9 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 276 | 2 | 13 |
| 2016 | 3 | 50 | 0 | 28 |
| 2017 | 5 | 181 | 0 | 17 |
| 2018 | 8 | 150 | 0 | 15 |
| 2019 | 0 | — | 2 | 16 |
| 2020 | 6 | 216 | 1 | 30 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 3 | 216 | 0 | 16 |
| 2023 | 6 | 137 | 0 | 20 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Entropy EasyFit 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 as stated in the FDA summary.
https://510kreport.com/device/K103129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103129: Entropy Easyfit Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103129
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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