510(k) · Cleared
ClearedNim-Spine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed · ETN Stimulator, Nerve
Cleared on Jun 18, 2003 as substantially equivalent to K923315 (Nicolet Instrument Corp., 1992) and 5 other predicates after a 35-day review. Its family tree reaches back 3 generations to 1998. 1 of the 52 devices in its family, counting itself, has a Class I recall. 40 later devices descend from it.
- Decided
- Jun 18, 2003
- Review
- 35 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K980148 (1998). 11 ancestors in all, the oldest K842956 (1984). 40 later devices descend from it, 4 citing it directly. 1 of the 52 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK980148 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1998
- 2 generations backK992869 Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 1999
- 1 generation backK014165 Stimulus - Dissection InstrumentsMedtronic Xomed, Inc. · 2002
- This deviceK031510 Nim-SpineMedtronic Xomed · 2003
- Descendant · cites it directly · 30 of its ownK083124 NIM 3.0Medtronic Xomed, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 9 of its ownK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- Descendant · 2 generations on · 7 of its ownK162313 NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
- Descendant · cites it directly · 6 of its ownK100992 NeuralmasInnovative Surgical Solutions, LLC ("Iss") · 2010
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200759 NIM Vital, Nerve Integrity Monitor2 generations on · 2020
Most influential descendants
Showing 5 of 40 · See all- K083124NIM 3.0Medtronic Xomed, Inc. · 2009 · cites it directly30descendants
- K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019 · 2 generations on9descendants
- K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017 · 2 generations on7descendants
- K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · 2 generations on7descendants
- K100992NeuralmasInnovative Surgical Solutions, LLC ("Iss") · 2010 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980148 | Neurosign 800, 8 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1998 | — |
| −2 | K992869 | Xomed Ball-Tip Monopolar Stimulator Probe | Xomed, Inc. | 1999 | — |
| −1 | K014165 | Stimulus - Dissection Instruments | Medtronic Xomed, Inc. | 2002 | — |
| 0 (this device) | K031510 | Nim-Spine | Medtronic Xomed | 2003 | — |
| +1 | K083124 | NIM 3.0 | Medtronic Xomed, Inc. | 2009 | 3 |
| +2 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +2 | K162313 | NuVasive Next Generation NVM5 System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 3 |
| +1 | K100992 | Neuralmas | Innovative Surgical Solutions, LLC ("Iss") | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 1 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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? (7)
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 |
|---|---|---|---|
| * | K923315 | Nicolet Ark SystemSummary page 2…entation, design, technology, system features, functions, and principle of operation of the NIM Spine are substantially equivalent to the Nicolet Viking IV, (K9233 15,890495, K880573,K842956) described as used with the Nicolet Bravo system, (K991054) and Neurosign 800 devices. The M… | 1992 |
| * | K890495 | Nicolet Viking II SystemSummary page 2…design, technology, system features, functions, and principle of operation of the NIM Spine are substantially equivalent to the Nicolet Viking IV, (K9233 15,890495, K880573,K842956) described as used with the Nicolet Bravo system, (K991054) and Neurosign 800 devices. The Monopola… | 1989 |
| * | K880573 | Modified Nicolet Viking SystemSummary page 2…technology, system features, functions, and principle of operation of the NIM Spine are substantially equivalent to the Nicolet Viking IV, (K9233 15,890495, K880573,K842956) described as used with the Nicolet Bravo system, (K991054) and Neurosign 800 devices. The Monopolar Stimula… | 1988 |
| * | K842956 | Nicolet VikingSummary page 2…ogy, system features, functions, and principle of operation of the NIM Spine are substantially equivalent to the Nicolet Viking IV, (K9233 15,890495, K880573,K842956) described as used with the Nicolet Bravo system, (K991054) and Neurosign 800 devices. The Monopolar Stimulating Ins… | 1984 |
| * | K991054 | Bravo Multi-Modality SystemSummary page 2…of the NIM Spine are substantially equivalent to the Nicolet Viking IV, (K9233 15,890495, K880573,K842956) described as used with the Nicolet Bravo system, (K991054) and Neurosign 800 devices. The Monopolar Stimulating Instrumentationis equivalent to Medtronic Xomed’s Stimulus/ Dissecti… | 1999 |
| * | K014165 | Stimulus - Dissection Instruments | 2002 |
| * | — | Neurosign 800 Named without a submission number |
What descends from it? (40)
See all 404 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 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K083124 (Medtronic Xomed, Inc., 2009) has gone furthest, with 30 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 | — |
What is it indicated for?
This device is intended 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. This device is indicated for locating and identifying cranial and peripheral motor nerves during surgery, including spinal nerve roots.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031510: Nim-Spine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031510
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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