510(k) · Cleared
ClearedNeurovision Nerve Locator Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurovision Medical Products, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Sep 30, 2011 as substantially equivalent to K954601 (Rln Systems, Inc., 1995) and 1 other predicate after a 255-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Sep 30, 2011
- Review
- 255 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K954601 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK954601 Nerve Locator/Monitor System ModificationRln Systems, Inc. · 1995
- This deviceK110140 Neurovision Nerve Locator MonitorNeurovision Medical Products, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK121931 Nondisposable Stimulating InstrumentsNeurovision Medical Products, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K121931Nondisposable Stimulating InstrumentsNeurovision Medical Products, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954601 | Nerve Locator/Monitor System Modification | Rln Systems, Inc. | 1995 | — |
| 0 (this device) | K110140 | Neurovision Nerve Locator Monitor | Neurovision Medical Products, Inc. | 2011 | — |
| +1 | K121931 | Nondisposable Stimulating Instruments | Neurovision Medical Products, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K954601 | Nerve Locator/Monitor System ModificationSummary page 1…d Response Electrical Stimulator Regulatory Class: Class 11 Product Code: GWF, ETN Predicate Devices Neurovision, Nerve Locator/Monitor System Modification NVOO4 model (K954601) NuVasive, INS-i lntraoperative Nerve Surveillance System (K002677) Device Description The Neurovision Nerve Locator Monitor Mod… | 1995 |
| * | K002677 | Nuvasive Ins-1 Intraoperative Nerve Surveillance SystemSummary page 1…Code: GWF, ETN Predicate Devices Neurovision, Nerve Locator/Monitor System Modification NVOO4 model (K954601) NuVasive, INS-i lntraoperative Nerve Surveillance System (K002677) Device Description The Neurovision Nerve Locator Monitor Model NVOO6 is a single channel evoked EMG device for surgical nerve l… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121931 | Nondisposable Stimulating Instruments | 2012 | 0 |
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. 2011, 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 Neurovision Nerve Locator Monitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG Monitor with integrated detecting or warning capability. The device is intended to assist the surgeon in locating motor nerves that are at risk in surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110140 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110140: Neurovision Nerve Locator Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110140
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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