510(k) · Cleared
ClearedNerve Locator/Monitor System Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rln Systems, Inc. · ETN Stimulator, Nerve
Cleared on Dec 22, 1995 after a 101-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Dec 22, 1995
- Review
- 101 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK954601 Nerve Locator/Monitor System ModificationRln Systems, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK110140 Neurovision Nerve Locator MonitorNeurovision Medical Products, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK121931 Nondisposable Stimulating InstrumentsNeurovision Medical Products, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK110138 Paired Hydrogel ElectrodeNeurovision Medical Products, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK102862 Neurovision SE (Nerveana)Neurovision Medical Products, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K110140Neurovision Nerve Locator MonitorNeurovision Medical Products, Inc. · 2011 · cites it directly1descendant
- K121931Nondisposable Stimulating InstrumentsNeurovision Medical Products, Inc. · 2012 · 2 generations on0descendants
- K110138Paired Hydrogel ElectrodeNeurovision Medical Products, Inc. · 2011 · cites it directly0descendants
- K102862Neurovision SE (Nerveana)Neurovision Medical Products, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954601 | Nerve Locator/Monitor System Modification | Rln Systems, Inc. | 1995 | — |
| +1 | K110140 | Neurovision Nerve Locator Monitor | Neurovision Medical Products, Inc. | 2011 | — |
| +2 | K121931 | Nondisposable Stimulating Instruments | Neurovision Medical Products, Inc. | 2012 | — |
| +1 | K110138 | Paired Hydrogel Electrode | Neurovision Medical Products, Inc. | 2011 | — |
| +1 | K102862 | Neurovision SE (Nerveana) | Neurovision Medical Products, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ETN? 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 ETN device
- #1 K251672 NIM Essence™ EMG Endotracheal Tube…score 12.3 · 6 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
3 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?
- Of its descendants, K110140 (Neurovision Medical Products, Inc., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETN
98in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ETN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETN
1,145in 2025
MAUDE reports naming product code ETN, 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 | 2 | — | 0 | 5 |
| 2008 | 2 | — | 1 | 5 |
| 2009 | 5 | 115 | 0 | 22 |
| 2010 | 3 | 168 | 1 | 26 |
| 2011 | 9 | 115 | 0 | 55 |
| 2012 | 7 | 179 | 0 | 187 |
| 2013 | 1 | — | 0 | 270 |
| 2014 | 2 | — | 0 | 137 |
| 2015 | 1 | — | 0 | 202 |
| 2016 | 2 | — | 1 | 145 |
| 2017 | 0 | — | 0 | 117 |
| 2018 | 0 | — | 0 | 250 |
| 2019 | 0 | — | 2 | 314 |
| 2020 | 1 | — | 1 | 238 |
| 2021 | 1 | — | 1 | 197 |
| 2022 | 2 | — | 0 | 247 |
| 2023 | 5 | 98 | 1 | 390 |
| 2024 | 2 | — | 0 | 748 |
| 2025 | 1 | — | 0 | 1,145 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K954601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954601: Nerve Locator/Monitor System Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954601
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026