510(k) · Cleared
ClearedAuragen Cortical Surface Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Neurosciences · GYC Electrode, Cortical
Cleared on Oct 10, 2008 as substantially equivalent to K926424 (Radionics, Inc., 1993) after a 63-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Oct 10, 2008
- Review
- 63 days
- Class
- Class II
- Product code
- GYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926424 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK926424 Cortical Surf Epilepsy Elect Depth Elec Epilep MonRadionics, Inc. · 1993
- This deviceK082250 Auragen Cortical Surface ElectrodesIntegra Neurosciences · 2008
View 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) | K082250 | Auragen Cortical Surface Electrodes | Integra Neurosciences | 2008 | — |
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…GYC Substantial Equivalence: The modified cortical surface electrodes are substantially equivalent to the cortical surface electrodes cleared by the FDA under 510(k) (K926424). The design, intended use, materials of composition, functional/performance specifications, manufacturing process are equivalent… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K926424.
How does its category compare?
All GYC devicesGYC Electrode, Cortical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Auragen TM Cortical Surface Electrodes are intended for the intraoperative recording of EEG signals at the cortical surface of the brain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082250 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082250: Auragen Cortical Surface Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082250
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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