510(k) · Cleared
ClearedCortical Surf Epilepsy Elect Depth Elec Epilep Mon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics, Inc. · GYC Electrode, Cortical
Cleared on Nov 19, 1993 after a 331-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Nov 19, 1993
- Review
- 331 days
- Class
- Class II
- Product code
- GYC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK926424 Cortical Surf Epilepsy Elect Depth Elec Epilep MonRadionics, Inc. · 1993
- Descendant · cites it directly · 2 of its ownK961942 Epidural Peg Electrode (EP), Sphenoidal Electrode (Eds) and Foramen…Radionics, Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK201678 iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK222706 iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK082250 Auragen Cortical Surface ElectrodesIntegra Neurosciences · 2008
Most influential descendants
Showing 4 of 4 · See all- K961942Epidural Peg Electrode (EP), Sphenoidal Electrode (Eds) and Foramen, Ovale Depth…Radionics, Inc. · 1997 · cites it directly2descendants
- K201678iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc. · 2021 · 2 generations on1descendant
- K222706iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc. · 2022 · 3 generations on0descendants
- K082250Auragen Cortical Surface ElectrodesIntegra Neurosciences · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926424 | Cortical Surf Epilepsy Elect Depth Elec Epilep Mon | Radionics, Inc. | 1993 | — |
| +1 | K961942 | Epidural Peg Electrode (EP), Sphenoidal Electrode (Eds) and Foramen, Ovale… | Radionics, Inc. | 1997 | — |
| +2 | K201678 | iCE-SG Subcutaneous Electrode Arrays | Ice Neurosystems, Inc. | 2021 | — |
| +3 | K222706 | iCE-SG2 Subcutaneous Electrode Kit | Ice Neurosystems, Inc. | 2022 | — |
| +1 | K082250 | Auragen Cortical Surface Electrodes | Integra Neurosciences | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2008 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GYC? 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 GYC device
- #1 K191186 Subdural Strip/Intraoperative Split Electrode…score 11.3 · 3 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 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, K961942 (Radionics, Inc., 1997) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GYC devicesGYC Electrode, Cortical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GYC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GYC
Too few GYC 510(k)s in any year since 2007 to give a median.
Recalls per year · GYC
1in 2013
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GYC
2in 2025
MAUDE reports naming product code GYC, 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 | 0 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 3 | 6 |
| 2012 | 0 | — | 1 (1) | 17 |
| 2013 | 0 | — | 1 | 5 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 2 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K926424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K926424: Cortical Surf Epilepsy Elect Depth Elec Epilep Mon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926424
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026