510(k) · Cleared
Recalled · Class II · 2017Nexstim Eximia Navigated Brain Stimulation System
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 Dec 8, 2009 after a 204-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 8, 2009
- Review
- 204 days
- Class
- Class II
- Product code
- GWF
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK091457 Nexstim Eximia Navigated Brain Stimulation SystemNexstim OY · 2009
- Descendant · cites it directly · 0 of its ownK112881 Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS…Nexstim OY · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK101887 Confident Surgery Suite 300, Model CSS300Surgiceye GmbH · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091457 | Nexstim Eximia Navigated Brain Stimulation System | Nexstim OY | 2009 | — |
| +1 | K112881 | Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with… | Nexstim OY | 2012 | 1 |
| +1 | K101887 | Confident Surgery Suite 300, Model CSS300 | Surgiceye GmbH | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 14, 2017 | Class II | Z-2319-2017 | 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?
- Of its descendants, K112881 (Nexstim OY, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 eXimia Navigated Brain Stimulation System (NBS System) is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K091457 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091457: Nexstim Eximia Navigated Brain Stimulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091457
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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