510(k) · Cleared
ClearedCeribell Instant EEG Headband
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceribell, Inc. · GXY Electrode, Cutaneous
Cleared on Aug 21, 2017 as substantially equivalent to K092828 (Hydrodot, Inc., 2010) after a 95-day review. Its family tree reaches back 1 generation to 2010. 21 later devices descend from it.
- Decided
- Aug 21, 2017
- Review
- 95 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092828 (2010). 21 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK092828 Statnet, Model 3100Hydrodot, Inc. · 2010
- This deviceK171459 Ceribell Instant EEG HeadbandCeribell, Inc. · 2017
- Descendant · cites it directly · 9 of its ownK183529 AE-120A EEG Head SetNihon Kohden Corporation · 2019
- Descendant · cites it directly · 5 of its ownK210805 Ceribell Instant EEG HeadbandCeribell, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK202334 NeuronauteBioserenity Sas · 2020
- Descendant · 2 generations on · 3 of its ownK232052 Ceribell Instant EEG HeadbandCeribell, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK203827 REMIEpitel, Inc. · 2021
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K183529AE-120A EEG Head SetNihon Kohden Corporation · 2019 · cites it directly9descendants
- K210805Ceribell Instant EEG HeadbandCeribell, Inc. · 2021 · cites it directly5descendants
- K202334NeuronauteBioserenity Sas · 2020 · 2 generations on4descendants
- K232052Ceribell Instant EEG HeadbandCeribell, Inc. · 2023 · 2 generations on3descendants
- K203827REMIEpitel, Inc. · 2021 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092828 | Statnet, Model 3100 | Hydrodot, Inc. | 2010 | — |
| 0 (this device) | K171459 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2017 | — |
| +1 | K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | 2019 | — |
| +1 | K210805 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2021 | — |
| +2 | K202334 | Neuronaute | Bioserenity Sas | 2020 | — |
| +2 | K232052 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2023 | — |
| +1 | K203827 | REMI | Epitel, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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 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 |
|---|---|---|---|
| * | K092828 | Statnet, Model 3100Summary page 4…: Cutaneous electrode (21CFR 882.1320) Device Class: II Product Code: GXY Predicate Devices: Hydrodot Statnet EEG Headpiece (K092828). Date Prepared: August 17, 2017 Device Description: The Ceribell Instant EEG Headband is a 10 electrode EEG headband. The head… | 2010 |
What descends from it? (21)
See all 215 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?
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs in patients of 6 years and older. The Instant EEG Headband is intended for prescription use in the home, healthcare facility, or clinical research environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171459: Ceribell Instant EEG Headband.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171459
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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