510(k) · Cleared
ClearedNerve Integrity Monitor-2 (Nim-2 XL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed-Treace, Inc. · ETN Stimulator, Nerve
Cleared on May 13, 1994 after a 245-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 48 devices in its family, counting itself, has a Class I recall. 47 later devices descend from it.
- Decided
- May 13, 1994
- Review
- 245 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 0
47 later devices descend from it, 3 citing it directly. 1 of the 48 devices in this family, counting this one, has a Class I recall.
- This deviceK934426 Nerve Integrity Monitor-2 (Nim-2 XL)Xomed-Treace, Inc. · 1994
- Descendant · cites it directly · 39 of its ownK982595 NIM4Xomed, Inc. · 1998
- Descendant · 2 generations on · 31 of its ownK024316 Nim-PRSMedtronic Xomed, Inc. · 2003
- Descendant · 3 generations on · 30 of its ownK083124 NIM 3.0Medtronic Xomed, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 16 of its ownK070608 Smartep, Model M010000Intelligent Hearing Systems · 2007
- Descendant · 3 generations on · 12 of its ownK123843 Neuroepg SystemStrohl Medical Technologies · 2013
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200759 NIM Vital, Nerve Integrity Monitor4 generations on · 2020
Most influential descendants
Showing 5 of 47 · See all- K982595NIM4Xomed, Inc. · 1998 · cites it directly39descendants
- K024316Nim-PRSMedtronic Xomed, Inc. · 2003 · 2 generations on31descendants
- K083124NIM 3.0Medtronic Xomed, Inc. · 2009 · 3 generations on30descendants
- K070608Smartep, Model M010000Intelligent Hearing Systems · 2007 · 2 generations on16descendants
- K123843Neuroepg SystemStrohl Medical Technologies · 2013 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934426 | Nerve Integrity Monitor-2 (Nim-2 XL) | Xomed-Treace, Inc. | 1994 | — |
| +1 | K982595 | NIM4 | Xomed, Inc. | 1998 | — |
| +2 | K024316 | Nim-PRS | Medtronic Xomed, Inc. | 2003 | — |
| +3 | K083124 | NIM 3.0 | Medtronic Xomed, Inc. | 2009 | 3 |
| +2 | K070608 | Smartep, Model M010000 | Intelligent Hearing Systems | 2007 | — |
| +3 | K123843 | Neuroepg System | Strohl Medical Technologies | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 1 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 7 | 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.
1 device in this family has a Class I recall. 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (47)
See all 473 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc. · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K982595 (Xomed, Inc., 1998) has gone furthest, with 39 descendants 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/K934426 · printed Nov 5, 2026
Cite this page
510(k) Report. “K934426: Nerve Integrity Monitor-2 (Nim-2 XL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K934426
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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