510(k) · Cleared
Recalled · Class I · 2019Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes, Intraoperative Subdural Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ad-Tech Medical Instrument Corp · GYC Electrode, Cortical
Cleared on May 30, 2006 as substantially equivalent to K970587 (Ad-Tech Medical Instrument Corp, 1997) and 2 other predicates after a 179-day review. Its family tree reaches back 2 generations to 1985. 1 of the 14 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- May 30, 2006
- Review
- 179 days
- Class
- Class II
- Product code
- GYC
- Recalls
- 2 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 2 generations to K850342 (1985). 4 ancestors in all. 9 later devices descend from it, 5 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK850342 Wyler Subdural Strip ElectrodeAd-Tech Medical Instrument Corp · 1985
- 1 generation backK021144 Subdural Strip ElectrodeNicolet Biomedical, Inc. · 2002
- This deviceK053363 Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural…Ad-Tech Medical Instrument Corp · 2006
- Descendant · cites it directly · 4 of its ownK191186 Subdural Strip/Intraoperative Split Electrode, Subdural…Ad-Tech Medical Instrument Corporation · 2020
- Descendant · cites it directly · 1 of its ownK082474 PMT Subdural Cortical ElectrodesPmt Corp. · 2009
- Descendant · 2 generations on · 0 of its ownK242618 Layer 7-TPrecision Neuroscience, Corp. · 2025
- Descendant · cites it directly · 0 of its ownK221123 WISE Cortical Strip (WCS)Wise S.R.L. · 2022
- Descendant · 2 generations on · 0 of its ownK211954 Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative…Spes Medica Srl · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K191186Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid…Ad-Tech Medical Instrument Corporation · 2020 · cites it directly4descendants
- K082474PMT Subdural Cortical ElectrodesPmt Corp. · 2009 · cites it directly1descendant
- K242618Layer 7-TPrecision Neuroscience, Corp. · 2025 · 2 generations on0descendants
- K221123WISE Cortical Strip (WCS)Wise S.R.L. · 2022 · cites it directly0descendants
- K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip…Spes Medica Srl · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850342 | Wyler Subdural Strip Electrode | Ad-Tech Medical Instrument Corp | 1985 | — |
| −1 | K021144 | Subdural Strip Electrode | Nicolet Biomedical, Inc. | 2002 | — |
| 0 (this device) | K053363 | Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes… | Ad-Tech Medical Instrument Corp | 2006 | — |
| +1 | K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative… | Ad-Tech Medical Instrument Corporation | 2020 | — |
| +1 | K082474 | PMT Subdural Cortical Electrodes | Pmt Corp. | 2009 | — |
| +2 | K242618 | Layer 7-T | Precision Neuroscience, Corp. | 2025 | — |
| +1 | K221123 | WISE Cortical Strip (WCS) | Wise S.R.L. | 2022 | — |
| +2 | K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid… | Spes Medica Srl | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K970587 | AD-Tech Subdural ElectrodeSummary page 1…mmon Name: Cortical Electrodes Classification Name: 21 CFR 882.1310, Cortical Electrode Predicate Device(s): 510(k) Number: K970587, K923803 Manufacture: AD-TECH Medical Instrument Corporation Trade Name:… | 1997 |
| * | K923803 | AD-Tech Sub Dural ElectrodedsSummary page 1…: Cortical Electrodes Classification Name: 21 CFR 882.1310, Cortical Electrode Predicate Device(s): 510(k) Number: K970587, K923803 Manufacture: AD-TECH Medical Instrument Corporation Trade Name: Subdural… | 1992 |
| * | K021144 | Subdural Strip ElectrodeSummary page 1…Manufacture: AD-TECH Medical Instrument Corporation Trade Name: Subdural Electrode 510(k) Number: K021144 Manufacture: Nicolet Biomedical Corporation Trade Name: Subdural Strip E… | 2002 |
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid… | 2020 | 4 |
| K082474 | PMT Subdural Cortical Electrodes | 2009 | 1 |
| K221123 | WISE Cortical Strip (WCS) | 2022 | 0 |
| K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) | 2020 | 0 |
| K183437 | AirRay Subdural Cortical Electrodes | 2019 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 18, 2019 | Class II | Z-2406-2019 | Employee error | Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use. |
| Dec 18, 2012 | Class I | Z-0892-2013 | Device Design | The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the cortical tissue with the electrode is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 16.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K191186 (Ad-Tech Medical Instrument Corporation, 2020) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K970587.
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 AD-TECH Subdural Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053363 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053363: Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes, Intraoperative Subdural Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053363
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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