510(k) · Cleared
ClearedSubdural Strip Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nicolet Biomedical, Inc. · GYC Electrode, Cortical
Cleared on Jun 24, 2002 as substantially equivalent to K970587 (Ad-Tech Medical Instrument Corp, 1997) and 2 other predicates after a 76-day review. Its family tree reaches back 1 generation to 1985. 1 of the 14 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Jun 24, 2002
- Review
- 76 days
- Class
- Class II
- Product code
- GYC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K850342 (1985). 3 ancestors in all. 10 later devices descend from it, 1 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK850342 Wyler Subdural Strip ElectrodeAd-Tech Medical Instrument Corp · 1985
- This deviceK021144 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
- Descendant · 2 generations on · 0 of its ownK221123 WISE Cortical Strip (WCS)Wise S.R.L. · 2022
Showing 5 of 10 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 10 · See all- 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
- K221123WISE Cortical Strip (WCS)Wise S.R.L. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850342 | Wyler Subdural Strip Electrode | Ad-Tech Medical Instrument Corp | 1985 | — |
| 0 (this device) | 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 | — |
| +2 | K221123 | WISE Cortical Strip (WCS) | Wise S.R.L. | 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 |
|---|---|---|
| 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), 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…Cortical Electrode Classification Name: 21 CFR 882.1310; Product Code: GYC Predicate Device: 510(k) Number: K970587, K923803, K850342 Manufacture: Ad-Tech Medical Instrument Cop.… | 1997 |
| * | K923803 | AD-Tech Sub Dural ElectrodedsSummary page 1…Cortical Electrode Classification Name: 21 CFR 882.1310; Product Code: GYC Predicate Device: 510(k) Number: K970587, K923803, K850342 Manufacture: Ad-Tech Medical Instrument Cop.… | 1992 |
| * | K850342 | Wyler Subdural Strip ElectrodeSummary page 1…rtical Electrode Classification Name: 21 CFR 882.1310; Product Code: GYC Predicate Device: 510(k) Number: K970587, K923803, K850342 Manufacture: Ad-Tech Medical Instrument Cop. Trade Na… | 1985 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053363 | Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes… Class I | 2006 | 9 |
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?
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 Nicolet Subdural Strip Electrodes can be temporarily placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021144 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021144: Subdural Strip Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021144
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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