510(k) · Cleared
ClearedEpidural Peg Electrode (EP), Sphenoidal Electrode (Eds) and Foramen, Ovale Depth Electrode (ED-FO) for Epilepsy Monitori
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics, Inc. · GYC Electrode, Cortical
Cleared on Aug 18, 1997 as substantially equivalent to K926424 (Radionics, Inc., 1993) after a 455-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Aug 18, 1997
- Review
- 455 days
- Class
- Class II
- Product code
- GYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926424 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK926424 Cortical Surf Epilepsy Elect Depth Elec Epilep MonRadionics, Inc. · 1993
- This deviceK961942 Epidural Peg Electrode (EP), Sphenoidal Electrode (Eds) and Foramen…Radionics, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK201678 iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK222706 iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926424 | Cortical Surf Epilepsy Elect Depth Elec Epilep Mon | Radionics, Inc. | 1993 | — |
| 0 (this device) | K961942 | Epidural Peg Electrode (EP), Sphenoidal Electrode (Eds) and Foramen, Ovale… | Radionics, Inc. | 1997 | — |
| +1 | K201678 | iCE-SG Subcutaneous Electrode Arrays | Ice Neurosystems, Inc. | 2021 | — |
| +2 | K222706 | iCE-SG2 Subcutaneous Electrode Kit | Ice Neurosystems, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | K926424 | Cortical Surf Epilepsy Elect Depth Elec Epilep MonSummary page 1…ording of electrical signals for epilepsy monitoring at the surface and subsurface levels of the brain. Predicate Device: Radionics Cortical Surface & Depth Electrodes (K926424). Manufacturing Facility Address: Radionics, Inc. ( 76 Cambridge St. Burlington, MA 01803 Performance Standard: No applicable… | 1993 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201678 | iCE-SG Subcutaneous Electrode Arrays | 2021 | 1 |
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 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 | — |
What is it indicated for?
Radionics Epidural Peg, Sphenoidal and Foramen Ovale Depth Electrodes are indicated for intraoperative recording of electrical signals for epilepsy monitoring at the surface and subsurface levels of the brain.
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/K961942 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961942: Epidural Peg Electrode (EP), Sphenoidal Electrode (Eds) and Foramen, Ovale Depth Electrode (ED-FO) for Epilepsy Monitori.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961942
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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