510(k) · Cleared
ClearedStimulus - Dissection Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · ETN Stimulator, Nerve
Cleared on Jan 22, 2002 as substantially equivalent to K992869 (Xomed, Inc., 1999) after a 34-day review. Its family tree reaches back 2 generations to 1998. 1 of the 68 devices in its family, counting itself, has a Class I recall. 65 later devices descend from it.
- Decided
- Jan 22, 2002
- Review
- 34 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980148 (1998). 65 later devices descend from it, 4 citing it directly. 1 of the 68 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK980148 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1998
- 1 generation backK992869 Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 1999
- This deviceK014165 Stimulus - Dissection InstrumentsMedtronic Xomed, Inc. · 2002
- Descendant · cites it directly · 40 of its ownK031510 Nim-SpineMedtronic Xomed · 2003
- Descendant · cites it directly · 35 of its ownK031003 Stimulus/Dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 30 of its ownK083124 NIM 3.0Medtronic Xomed, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 19 of its ownK090838 Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009
- Descendant · cites it directly · 17 of its ownK103128 Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip…Cadwell Lab, Inc. · 2011
Showing 5 of 65 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 65 · See all- K031510Nim-SpineMedtronic Xomed · 2003 · cites it directly40descendants
- K031003Stimulus/Dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc. · 2003 · cites it directly35descendants
- K083124NIM 3.0Medtronic Xomed, Inc. · 2009 · 2 generations on30descendants
- K090838Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009 · 2 generations on19descendants
- K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…Cadwell Lab, Inc. · 2011 · cites it directly17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980148 | Neurosign 800, 8 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1998 | — |
| −1 | K992869 | Xomed Ball-Tip Monopolar Stimulator Probe | Xomed, Inc. | 1999 | — |
| 0 (this device) | K014165 | Stimulus - Dissection Instruments | Medtronic Xomed, Inc. | 2002 | — |
| +1 | K031510 | Nim-Spine | Medtronic Xomed | 2003 | — |
| +1 | K031003 | Stimulus/Dissection Instruments, Ball-Tip Probes | Medtronic Xomed, Inc. | 2003 | 1 |
| +2 | K083124 | NIM 3.0 | Medtronic Xomed, Inc. | 2009 | 3 |
| +2 | K090838 | Stimulus/Dissection Instruments | Axon Systems, Inc. | 2009 | — |
| +1 | K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip… | Cadwell Lab, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 1 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K992869 | Xomed Ball-Tip Monopolar Stimulator ProbeSummary page 2…urological stimula- tion feature of the Stimulus-Dissection Instrument is substantially equivalent to Medtronic Xomed Monopolar Stimulator Probe originally described in K992869. The design, technology, features, function, and intended use of the mechanical dissection feature is substantially equivalent t… | 1999 |
What descends from it? (65)
See all 654 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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K031510 (Medtronic Xomed, 2003) has gone furthest, with 40 descendants of its own.
- 6 other devices also cite its predicate K992869.
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?
The Stimulus - Dissection Instruments are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
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/K014165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014165: Stimulus - Dissection Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014165
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026