510(k) · Cleared
ClearedStainless Steel Cortac Cortical Electrode (2111)/Plantinum Cortac Cortical Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pmt Corp. · GYC Electrode, Cortical
Cleared on Mar 19, 1997 after a 147-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Mar 19, 1997
- Review
- 147 days
- Class
- Class II
- Product code
- GYC
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK964224 Stainless Steel Cortac Cortical Electrode (2111)/Plantinum Cortac…Pmt Corp. · 1997
- Descendant · cites it directly · 1 of its ownK082474 PMT Subdural Cortical ElectrodesPmt Corp. · 2009
- Descendant · 2 generations on · 0 of its ownK192764 NeuroOne Cortical ElectrodeNeuroone, Inc. · 2019
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 |
|---|---|---|---|---|---|
| 0 (this device) | K964224 | Stainless Steel Cortac Cortical Electrode (2111)/Plantinum Cortac Cortical… | Pmt Corp. | 1997 | — |
| +1 | K082474 | PMT Subdural Cortical Electrodes | Pmt Corp. | 2009 | — |
| +2 | K192764 | NeuroOne Cortical Electrode | Neuroone, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2019 | 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? (3)
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 |
|---|---|---|---|
| * | — | Ojemann Cortical Stimulator (OCS-1) Named without a submission number | |
| * | — | Wyler Subdural Strip Electrode Named without a submission number | |
| * | — | PMT 2111-4 stainless steel Cortac Cortical electrode Named without a submission number |
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 |
|---|---|---|---|
| K082474 | PMT Subdural Cortical Electrodes | 2009 | 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?
- Of its descendants, K082474 (Pmt Corp., 2009) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The Cortac Cortical Electrode is used intraoperatively for monitoring recordable electrical brain activity or Electroencephalography (EEG) when less invasive methods do not provide the electrophysiology data necessary.
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/K964224 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964224: Stainless Steel Cortac Cortical Electrode (2111)/Plantinum Cortac Cortical Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964224
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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