510(k) · Cleared
Recalled · 2011Nicolet Cortical Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Inc. · GYC Electrode, Cortical
Cleared on Dec 30, 2008 as substantially equivalent to K924226 (Radionics, Inc., 1993) and 1 other predicate after a 438-day review. Its family tree reaches back 1 generation to 1993. 1 of the 26 devices in its family, counting itself, has a Class I recall. 23 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 30, 2008
- Review
- 438 days
- Class
- Class II
- Product code
- GYC
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924226 (1993). 2 ancestors in all. 23 later devices descend from it, 4 citing it directly. 1 of the 26 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK924226 Ojemann Cortical StimulatorRadionics, Inc. · 1993 · Recalled
- This deviceK072964 Nicolet Cortical StimulatorCardinal Health, Inc. · 2008
- Descendant · cites it directly · 13 of its ownK110410 MS-120BK Electric Stimulator (Extension Unit)Nihon Kohden Corp. · 2011
- Descendant · 2 generations on · 9 of its ownK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- Descendant · cites it directly · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 5 of its ownK212166 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2022
- Descendant · 3 generations on · 4 of its ownK213849 SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K171581 Neuro Omega Systemcites it directly · 2017
Most influential descendants
Showing 5 of 23 · See all- K110410MS-120BK Electric Stimulator (Extension Unit)Nihon Kohden Corp. · 2011 · cites it directly13descendants
- K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019 · 2 generations on9descendants
- K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · cites it directly7descendants
- K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH · 2022 · 2 generations on5descendants
- K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924226 | Ojemann Cortical Stimulator | Radionics, Inc. | 1993 | 1 |
| 0 (this device) | K072964 | Nicolet Cortical Stimulator | Cardinal Health, Inc. | 2008 | — |
| +1 | K110410 | MS-120BK Electric Stimulator (Extension Unit) | Nihon Kohden Corp. | 2011 | — |
| +2 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +1 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 3 |
| +2 | K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022 | — |
| +3 | K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 1 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (2)
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 |
|---|---|---|---|
| * | K924226 | Ojemann Cortical StimulatorSummary page 1…al Stimulator Classification Name: Cortical Electrode, CFR 882.1310, Product Code: GYC, Class II Predicate Device(s): K924226 Ojemann Cortical Stimulator K040360 XLTEK EMU128 Switch Matrix 1.0 Desc… | 1993 |
| * | K040360 | EMU128S, Model EX-NW-128SSummary page 1…FR 882.1310, Product Code: GYC, Class II Predicate Device(s): K924226 Ojemann Cortical Stimulator K040360 XLTEK EMU128 Switch Matrix 1.0 Description of Device The Nicolet Cortical Stimulator supports clinician… | 2004 |
What descends from it? (23)
See all 234 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 5, 2011 | Not classified | Z-0801-2012 | Nonconforming Material/Component | CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report… |
| Oct 5, 2011 | Not classified | Z-0799-2012 | Nonconforming Material/Component | CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report… |
| Oct 5, 2011 | Not classified | Z-0800-2012 | Nonconforming Material/Component | CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report… |
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.
- K171581Neuro Omega SystemAlpha Omega Engineering, Ltd. · 2017 · Cites it directly · ◆ in the 2017 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. 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 Cortical Stimulator is intended for use in functional brain mapping procedures during treatment of patients with seizure disorder, providing stimulation via electrode pairs or a hand held bipolar probe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072964: Nicolet Cortical Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072964
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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