510(k) · Cleared
ClearedSen-4100 Electric Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Oct 6, 2008 as substantially equivalent to K020400 (Meps, LLC, 2002) after a 447-day review. Its family tree reaches back 1 generation to 2002. 14 later devices descend from it.
- Decided
- Oct 6, 2008
- Review
- 447 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020400 (2002). 14 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK020400 Digitimer D185 Multipulse Cortical StimulatorMeps, LLC · 2002
- This deviceK071969 Sen-4100 Electric StimulatorNihon Kohden America, 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 · 3 generations on · 4 of its ownK213849 SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022
- Descendant · 4 generations on · 3 of its ownK234092 SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024
- Descendant · 3 generations on · 3 of its ownK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · 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
- K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022 · 3 generations on4descendants
- K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024 · 4 generations on3descendants
- K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020400 | Digitimer D185 Multipulse Cortical Stimulator | Meps, LLC | 2002 | — |
| 0 (this device) | K071969 | Sen-4100 Electric Stimulator | Nihon Kohden America, Inc. | 2008 | — |
| +1 | K110410 | MS-120BK Electric Stimulator (Extension Unit) | Nihon Kohden Corp. | 2011 | — |
| +2 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +3 | K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022 | — |
| +4 | K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | 2024 | — |
| +3 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 GWF? 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 GWF device
- #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K020400 | Digitimer D185 Multipulse Cortical StimulatorSummary page 1…ponse Electrical Stimulator" per GWF. * The legally marketed equivalence: The predicate-marketed device is the Digitimer D1 85 Multipulse Cortical Stimulator, K020400, commercial distribution certification dated August 23, 2002. • A description of the device: The SEN-4100A is the stim… | 2002 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110410 | MS-120BK Electric Stimulator (Extension Unit) | 2011 | 13 |
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?
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWF
92in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWF
1,034in 2025
MAUDE reports naming product code GWF, 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 | 3 | 69 | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 5 | 178 | 0 | 1 |
| 2010 | 3 | 269 | 0 | 4 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 4 | 230 | 1 | 44 |
| 2013 | 3 | 174 | 0 | 89 |
| 2014 | 1 | — | 0 | 25 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 1 | — | 0 | 20 |
| 2017 | 3 | 169 | 0 | 60 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 94 |
| 2020 | 1 | — | 0 | 65 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 2 | — | 0 | 45 |
| 2023 | 2 | — | 0 | 150 |
| 2024 | 4 | 92 | 0 | 854 |
| 2025 | 1 | — | 0 | 1,034 |
| 2026 | 3 | 125 | 2 | — |
What is it indicated for?
Nihon Kohden Sen-4100 Electric Stimulator is used for the intraoperative diagnosis of acute dysfunction in corticospinal tract axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071969 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071969: Sen-4100 Electric Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071969
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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