510(k) · Cleared
ClearedNIM4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · ETN Stimulator, Nerve
Cleared on Sep 4, 1998 as substantially equivalent to K934426 (Xomed-Treace, Inc., 1994) after a 39-day review. Its family tree reaches back 1 generation to 1994. 1 of the 41 devices in its family, counting itself, has a Class I recall. 39 later devices descend from it.
- Decided
- Sep 4, 1998
- Review
- 39 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934426 (1994). 39 later devices descend from it, 2 citing it directly. 1 of the 41 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK934426 Nerve Integrity Monitor-2 (Nim-2 XL)Xomed-Treace, Inc. · 1994
- This deviceK982595 NIM4Xomed, Inc. · 1998
- Descendant · cites it directly · 31 of its ownK024316 Nim-PRSMedtronic Xomed, Inc. · 2003
- Descendant · 2 generations on · 30 of its ownK083124 NIM 3.0Medtronic Xomed, Inc. · 2009 · Recalled
- Descendant · cites it directly · 16 of its ownK070608 Smartep, Model M010000Intelligent Hearing Systems · 2007
- Descendant · 2 generations on · 12 of its ownK123843 Neuroepg SystemStrohl Medical Technologies · 2013
- Descendant · 3 generations on · 11 of its ownK132616 EPADSafeop Surgical, Inc. · 2014
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200759 NIM Vital, Nerve Integrity Monitor3 generations on · 2020
Most influential descendants
Showing 5 of 39 · See all- K024316Nim-PRSMedtronic Xomed, Inc. · 2003 · cites it directly31descendants
- K083124NIM 3.0Medtronic Xomed, Inc. · 2009 · 2 generations on30descendants
- K070608Smartep, Model M010000Intelligent Hearing Systems · 2007 · cites it directly16descendants
- K123843Neuroepg SystemStrohl Medical Technologies · 2013 · 2 generations on12descendants
- K132616EPADSafeop Surgical, Inc. · 2014 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934426 | Nerve Integrity Monitor-2 (Nim-2 XL) | Xomed-Treace, Inc. | 1994 | — |
| 0 (this device) | K982595 | NIM4 | Xomed, Inc. | 1998 | — |
| +1 | K024316 | Nim-PRS | Medtronic Xomed, Inc. | 2003 | — |
| +2 | K083124 | NIM 3.0 | Medtronic Xomed, Inc. | 2009 | 3 |
| +1 | K070608 | Smartep, Model M010000 | Intelligent Hearing Systems | 2007 | — |
| +2 | K123843 | Neuroepg System | Strohl Medical Technologies | 2013 | — |
| +3 | K132616 | EPAD | Safeop Surgical, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 1 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 6 | 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.
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? (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 |
|---|---|---|---|
| * | K934426 | Nerve Integrity Monitor-2 (Nim-2 XL)Summary page 1…hrough the use of state-of-the-art componentry. Other than the changes specifically described in this notification, the device remains the same as previously provided in K934426. 6.0 Intended Use This device is indicated for use in surgical procedures for patient-connected intraoperative nerve monitoring,… | 1994 |
What descends from it? (39)
See all 392 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 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 | — |
What is it indicated for?
This device is indicated for use in surgical procedures for patient-connected intraoperative nerve monitoring, i.e. assisting the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982595: NIM4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982595
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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