510(k) · Cleared
ClearedMS-120BK Electric Stimulator (Extension Unit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Corp. · GYC Electrode, Cortical
Cleared on Aug 4, 2011 as substantially equivalent to K072964 (Cardinal Health, Inc., 2008) and 4 other predicates after a 171-day review. Its family tree reaches back 5 generations to 1984. 13 later devices descend from it.
- Decided
- Aug 4, 2011
- Review
- 171 days
- Class
- Class II
- Product code
- GYC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K842956 (1984). 17 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 4 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 3 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 2 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 1 generation backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- This deviceK110410 MS-120BK Electric Stimulator (Extension Unit)Nihon Kohden Corp. · 2011
- Descendant · cites it directly · 9 of its ownK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK213849 SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022
- Descendant · 3 generations on · 3 of its ownK234092 SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024
- Descendant · 2 generations on · 3 of its ownK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK191723 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019 · cites it directly9descendants
- K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022 · 2 generations on4descendants
- K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024 · 3 generations on3descendants
- K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 2 generations on3descendants
- K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −4 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −3 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −2 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −1 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| 0 (this device) | K110410 | MS-120BK Electric Stimulator (Extension Unit) | Nihon Kohden Corp. | 2011 | — |
| +1 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +2 | K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022 | — |
| +3 | K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | 2024 | — |
| +2 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +3 | K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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.
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? (5)
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 |
|---|---|---|---|
| * | K072964 | Nicolet Cortical StimulatorSummary page 1…Class 11 Predicate Device(s): Nicolet Cortical Stimulator K072964 Ojemann Cortical Stimulator K924226 Digitimer D185 Muttipulse Cortical Stimula… | 2008 |
| * | K924226 | Ojemann Cortical StimulatorSummary page 1…Predicate Device(s): Nicolet Cortical Stimulator K072964 Ojemann Cortical Stimulator K924226 Digitimer D185 Muttipulse Cortical Stimulator K(020400 Axon Eclipse Neurological workstation… | 1993 |
| * | K020400 | Digitimer D185 Multipulse Cortical StimulatorSummary page 1…K072964 Ojemann Cortical Stimulator K924226 Digitimer D185 Muttipulse Cortical Stimulator K(020400 Axon Eclipse Neurological workstation K(050798 Nihon Kohden SEN-4100 Electric Stimulator… | 2002 |
| * | K050798 | Eclipse Neurological WorkstationSummary page 1…K924226 Digitimer D185 Muttipulse Cortical Stimulator K(020400 Axon Eclipse Neurological workstation K(050798 Nihon Kohden SEN-4100 Electric Stimulator K(071969… | 2005 |
| * | K071969 | Sen-4100 Electric StimulatorSummary page 1…K(020400 Axon Eclipse Neurological workstation K(050798 Nihon Kohden SEN-4100 Electric Stimulator K(071969 Page 1 of 5 Nihon Koh… | 2008 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K182542 (Safeop Surgical, Inc., 2019) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K072964.
How does its category compare?
All GYC devicesGYC Electrode, Cortical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
When the Low output is selected the MS-120BK is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders.
When High output is selected the MS-12OBK is used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
The system is intended for use by qualified medical personnel within a hospital or clinical environment. The stimulator is available for use on any patients as determined by the qualified medical personnel.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110410 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110410: MS-120BK Electric Stimulator (Extension Unit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110410
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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