510(k) · Cleared
ClearedNeon EEG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Incereb, Ltd. · GXY Electrode, Cutaneous
Cleared on Sep 29, 2015 as substantially equivalent to K062692 (Aspect Medical Systems, Inc., 2006) and 1 other predicate after a 110-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Sep 29, 2015
- Review
- 110 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002734 (2000). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK002734 Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106Aspect Medical Systems, Inc. · 2000
- 1 generation backK041670 Bis Pediatric SensorAspect Medical Systems, Inc. · 2004
- This deviceK151576 Neon EEGIncereb, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK243788 IceCap product lineBioserenity Medical Devices Group · 2025
Most influential descendants
Showing 1 of 1 · See all- K243788IceCap product lineBioserenity Medical Devices Group · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002734 | Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106 | Aspect Medical Systems, Inc. | 2000 | — |
| −1 | K041670 | Bis Pediatric Sensor | Aspect Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K151576 | Neon EEG | Incereb, Ltd. | 2015 | — |
| +1 | K243788 | IceCap product line | Bioserenity Medical Devices Group | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K062692 | Bis Bilateral SensorSummary page 4…erence Class II, Cutaneous Electrode, Product code: GXY, 21 CFR 882.1320, Predicate Devices Primary Predicate: Aspect Medical Systems' BIS Bilateral Sensor (K062692) Secondary Predicate: Aspect Medical Systems' BIS Pediatric Sensor (K041670) Intended Use / Indications for Use The N… | 2006 |
| * | K041670 | Bis Pediatric SensorSummary page 4…Predicate Devices Primary Predicate: Aspect Medical Systems' BIS Bilateral Sensor (K062692) Secondary Predicate: Aspect Medical Systems' BIS Pediatric Sensor (K041670) Intended Use / Indications for Use The NEON EEG is intended to be applied directly to the patient's scalp to enable recor… | 2004 |
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 |
|---|---|---|---|
| K243788 | IceCap product line | 2025 | 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 15 years and passes through 2 companies; a new generation was cleared every 11.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K243788 (Bioserenity Medical Devices Group, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062692.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 NEON EEG is intended to be applied directly to the patient's scalp to enable recordings of electrophysiological signals (such as EEG) on infants from birth. The NEON EEG is indicated for single use only and should be replaced after 12 hours of use.
The NEON EEG is not indicated for use with electro stimulation equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151576: Neon EEG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151576
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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