510(k) · Cleared
Recalled · Class II · 2017Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with Nexspeech (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexstim OY · GWF Stimulator, Electrical, Evoked Response
Cleared on May 22, 2012 as substantially equivalent to K091457 (Nexstim OY, 2009) and 1 other predicate after a 235-day review. Its family tree reaches back 1 generation to 1993. It has been recalled once.
- Decided
- May 22, 2012
- Review
- 235 days
- Class
- Class II
- Product code
- GWF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924226 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK924226 Ojemann Cortical StimulatorRadionics, Inc. · 1993 · Recalled
- This deviceK112881 Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS…Nexstim OY · 2012
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) | K112881 | Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with… | Nexstim OY | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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.
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? (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 |
|---|---|---|---|
| * | K091457 | Nexstim Eximia Navigated Brain Stimulation SystemSummary page 1…Predicate Predicate Equivalent Devices: Si 0(k) Number Manufacturer / Model Nexstimn Navigational K09 1457 Nexstim Oy / eXimia Brain Stimulation Navigated Brain… | 2009 |
| * | K924226 | Ojemann Cortical StimulatorSummary page 1…Navigated Brain (NBS) System 4 Stimulation System Nexstimn NBS System 4 K924226 Radionics, Inc. / with NEXSPEECH' Ojemann Cortical… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 14, 2017 | Class II | Z-2320-2017 | Use error | Software defect: the NBS software may accidentally generate duplicate copies of one or several files. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K091457.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The Nexstim Navigated Brain Stimulation System (NBS System) 4 is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System 4 provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. Nexstim NEXSPEECH®, when used together with the Nexstim NBS System 4, is indicated for noninvasive localization of cortical areas that do not contain essential…
Read the full statement (146 words)
The Nexstim Navigated Brain Stimulation System (NBS System) 4 is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System 4 provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning.
Nexstim NEXSPEECH®, when used together with the Nexstim NBS System 4, is indicated for noninvasive localization of cortical areas that do not contain essential speech function. Nexstim NEXSPEECH® provides information that may be used in pre-surgical planning in patients undergoing brain surgery. Intraoperatively, the localization information provided by NEXSPEECH is intended to be verified by direct cortical stimulation.
The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are not intended to be used during a surgical procedure. The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are intended to be used by trained clinical professionals.
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/K112881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112881: Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with Nexspeech (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112881
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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