510(k) · Cleared
ClearedHydrospot Eeg Electrode Model 1501, Hydrospot Leadwire Model 1500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physiometrix, Inc. · GXY Electrode, Cutaneous
Cleared on Apr 15, 1996 as substantially equivalent to K930080 (Physiometrix, Inc., 1993) after a 53-day review. Its family tree reaches back 1 generation to 1993. 24 later devices descend from it.
- Decided
- Apr 15, 1996
- Review
- 53 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930080 (1993). 24 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK930080 E*Net Neuromonitoring SystemPhysiometrix, Inc. · 1993
- This deviceK960732 Hydrospot Eeg Electrode Model 1501, Hydrospot Leadwire Model 1500Physiometrix, Inc. · 1996
- Descendant · cites it directly · 23 of its ownK033010 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- Descendant · 2 generations on · 15 of its ownK071449 BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007
- Descendant · 2 generations on · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 11 of its ownK082886 Zoom-100DCBrainscope Company, Inc. · 2009
- Descendant · 3 generations on · 8 of its ownK081551 Twin Neurotrac-IiiAstro-Med, Inc. · 2008
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K033010BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003 · cites it directly23descendants
- K071449BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007 · 2 generations on15descendants
- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · 2 generations on14descendants
- K082886Zoom-100DCBrainscope Company, Inc. · 2009 · 3 generations on11descendants
- K081551Twin Neurotrac-IiiAstro-Med, Inc. · 2008 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930080 | E*Net Neuromonitoring System | Physiometrix, Inc. | 1993 | — |
| 0 (this device) | K960732 | Hydrospot Eeg Electrode Model 1501, Hydrospot Leadwire Model 1500 | Physiometrix, Inc. | 1996 | — |
| +1 | K033010 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| +2 | K071449 | BRM3 Brain Monitor | Brainz Instruments, Ltd. | 2007 | — |
| +2 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| +3 | K082886 | Zoom-100DC | Brainscope Company, Inc. | 2009 | — |
| +3 | K081551 | Twin Neurotrac-Iii | Astro-Med, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K930080 | E*Net Neuromonitoring SystemSummary page 1…Dawn E. Frazer Director, Regulatory Affairs & Quality Assurance (508) 670-2422 (800) 474-9746 Model 1501, HydroSpot EEG Electrodes Model 1500, HydroSpot EEG Leadwires K930080, HydroDot NeuroMonitoring System Class II, CFR 21 Part 882.1320, Cutaneous Electrodes The HydroSpots are single-use, pre-gelled,… | 1993 |
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033010 | BRM2 Brain Monitor | 2003 | 23 |
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.
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 HydroSpots are intended as direct substitutes for existing reusable EEG electrodes.
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/K960732 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960732: Hydrospot Eeg Electrode Model 1501, Hydrospot Leadwire Model 1500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960732
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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