510(k) · Cleared
ClearedStatnet, Model 3100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydrodot, Inc. · GXY Electrode, Cutaneous
Cleared on Jan 29, 2010 after a 137-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 24 later devices descend from it.
- Decided
- Jan 29, 2010
- Review
- 137 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 2 citing it directly.
- This deviceK092828 Statnet, Model 3100Hydrodot, Inc. · 2010
- Descendant · cites it directly · 21 of its ownK171459 Ceribell Instant EEG HeadbandCeribell, Inc. · 2017
- Descendant · 2 generations on · 9 of its ownK183529 AE-120A EEG Head SetNihon Kohden Corporation · 2019
- Descendant · 2 generations on · 5 of its ownK210805 Ceribell Instant EEG HeadbandCeribell, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK202334 NeuronauteBioserenity Sas · 2020
- Descendant · 3 generations on · 3 of its ownK232052 Ceribell Instant EEG HeadbandCeribell, Inc. · 2023
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K171459Ceribell Instant EEG HeadbandCeribell, Inc. · 2017 · cites it directly21descendants
- K183529AE-120A EEG Head SetNihon Kohden Corporation · 2019 · 2 generations on9descendants
- K210805Ceribell Instant EEG HeadbandCeribell, Inc. · 2021 · 2 generations on5descendants
- K202334NeuronauteBioserenity Sas · 2020 · 3 generations on4descendants
- K232052Ceribell Instant EEG HeadbandCeribell, Inc. · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092828 | Statnet, Model 3100 | Hydrodot, Inc. | 2010 | — |
| +1 | K171459 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2017 | — |
| +2 | K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | 2019 | — |
| +2 | K210805 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2021 | — |
| +3 | K202334 | Neuronaute | Bioserenity Sas | 2020 | — |
| +3 | K232052 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (24)
See all 242 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?
- Of its descendants, K171459 (Ceribell, Inc., 2017) has gone furthest, with 21 descendants of its own.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
An Electroencepahiogram (EEG) electrode array intended for use in the ER, ICU and OR for recording of STAT EEGs in patients of 18 years of age and older.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092828 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092828: Statnet, Model 3100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092828
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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