510(k) · Cleared
ClearedNeurosign Avalanche Motor Nerve Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Magstim Company, Ltd. · ETN Stimulator, Nerve
Cleared on Jul 29, 2009 as substantially equivalent to K991583 (The Magstim Company, Ltd., 1999) after a 268-day review. Its family tree reaches back 2 generations to 1992. 4 later devices descend from it.
- Decided
- Jul 29, 2009
- Review
- 268 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923056 (1992). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK923056 Neurosign Model 100The Magstim Company, Ltd. · 1992 · Recalled
- 1 generation backK991583 Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999
- This deviceK083242 Neurosign Avalanche Motor Nerve MonitorThe Magstim Company, Ltd. · 2009
- Descendant · cites it directly · 2 of its ownK111647 C2 Nervemonitor System with AccessoriesInomed Medizintechnik GmbH · 2011
- Descendant · 2 generations on · 1 of its ownK152505 C2 NerveMonitor SystemInomed Medizintechnik GmbH · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK233001 Bioscope Neuromonitor DeviceBiosys Biyomedikal Muhendislik San. VE Tic. A.S. · 2024
- Descendant · 3 generations on · 0 of its ownK223254 C2 XploreInomed Medizintechnik GmbH · 2023
Most influential descendants
Showing 4 of 4 · See all- K111647C2 Nervemonitor System with AccessoriesInomed Medizintechnik GmbH · 2011 · cites it directly2descendants
- K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH · 2016 · 2 generations on1descendant
- K233001Bioscope Neuromonitor DeviceBiosys Biyomedikal Muhendislik San. VE Tic. A.S. · 2024 · cites it directly0descendants
- K223254C2 XploreInomed Medizintechnik GmbH · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923056 | Neurosign Model 100 | The Magstim Company, Ltd. | 1992 | 1 |
| −1 | K991583 | Neurosign 400, 4 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1999 | — |
| 0 (this device) | K083242 | Neurosign Avalanche Motor Nerve Monitor | The Magstim Company, Ltd. | 2009 | — |
| +1 | K111647 | C2 Nervemonitor System with Accessories | Inomed Medizintechnik GmbH | 2011 | — |
| +2 | K152505 | C2 NerveMonitor System | Inomed Medizintechnik GmbH | 2016 | 2 |
| +1 | K233001 | Bioscope Neuromonitor Device | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | 2024 | — |
| +3 | K223254 | C2 Xplore | Inomed Medizintechnik GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | K991583 | Neurosign 400, 4 Channel Motor Nerve MonitorSummary page 2…dectomy, mastoidectomy, skull-base 5.3 Predicate Devices The predicate device used in this submission is: * Neurosign® 400 Motor Nerve Monitor (reference K991583). 5.3.1 Comparison with the predicate device © The Magstim Company Ltd 17 July 2009… | 1999 |
What descends from it? (4)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 1 company; a new generation was cleared every 10.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K111647 (Inomed Medizintechnik GmbH, 2011) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K991583.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Neurosign Avalanche nerve monitor is intended to help surgeons locate, identify,
and preserve cranial motor nerves during surgery.
The intended uses of the Neurosign Avalanche Motor Nerve Monitor is:
2 channel thyroidectomy and parathyroidectomy, mastoidectomy
4 channel parotidectomy, mastoidectomy, skull-base
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083242: Neurosign Avalanche Motor Nerve Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083242
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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