510(k) · Cleared
ClearedAD-Tech Subdural Electrode
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 9, 1997 after an 80-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 12 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- May 9, 1997
- Review
- 80 days
- Class
- Class II
- Product code
- GYC
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- This deviceK970587 AD-Tech Subdural ElectrodeAd-Tech Medical Instrument Corp · 1997
- Descendant · cites it directly · 10 of its ownK021144 Subdural Strip ElectrodeNicolet Biomedical, Inc. · 2002
- Descendant · cites it directly · 9 of its ownK053363 Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural…Ad-Tech Medical Instrument Corp · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK191186 Subdural Strip/Intraoperative Split Electrode, Subdural…Ad-Tech Medical Instrument Corporation · 2020
- Descendant · 2 generations on · 1 of its ownK082474 PMT Subdural Cortical ElectrodesPmt Corp. · 2009
- Descendant · 3 generations on · 0 of its ownK242618 Layer 7-TPrecision Neuroscience, Corp. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K053363 Dual-Sided Interhemispheric Subdural Electrodes…cites it directly · 2006
Most influential descendants
Showing 5 of 11 · See all- K021144Subdural Strip ElectrodeNicolet Biomedical, Inc. · 2002 · cites it directly10descendants
- K053363Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes…Ad-Tech Medical Instrument Corp · 2006 · cites it directly9descendants
- K191186Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid…Ad-Tech Medical Instrument Corporation · 2020 · 2 generations on4descendants
- K082474PMT Subdural Cortical ElectrodesPmt Corp. · 2009 · 2 generations on1descendant
- K242618Layer 7-TPrecision Neuroscience, Corp. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970587 | AD-Tech Subdural Electrode | Ad-Tech Medical Instrument Corp | 1997 | — |
| +1 | K021144 | Subdural Strip Electrode | Nicolet Biomedical, Inc. | 2002 | — |
| +1 | K053363 | Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes… | Ad-Tech Medical Instrument Corp | 2006 | Class I |
| +2 | K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative… | Ad-Tech Medical Instrument Corporation | 2020 | — |
| +2 | K082474 | PMT Subdural Cortical Electrodes | Pmt Corp. | 2009 | — |
| +3 | K242618 | Layer 7-T | Precision Neuroscience, Corp. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 1 |
| 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K053363Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes, Intraoperative Subdural ElectrodesAd-Tech Medical Instrument Corp · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K021144 (Nicolet Biomedical, Inc., 2002) has gone furthest, with 10 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/K970587 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970587: AD-Tech Subdural Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970587
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026