510(k) · Cleared
ClearedStimulus/Dissection Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axon Systems, Inc. · ETN Stimulator, Nerve
Cleared on Jul 20, 2009 as substantially equivalent to K031003 (Medtronic Xomed, Inc., 2003) and 2 other predicates after a 115-day review. Its family tree reaches back 4 generations to 1998. 19 later devices descend from it.
- Decided
- Jul 20, 2009
- Review
- 115 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K980148 (1998). 10 ancestors in all, the oldest K923056 (1992). 19 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK980148 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1998
- 3 generations backK992869 Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 1999
- 2 generations backK014165 Stimulus - Dissection InstrumentsMedtronic Xomed, Inc. · 2002
- 1 generation backK031003 Stimulus/Dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc. · 2003 · Recalled
- This deviceK090838 Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009
- Descendant · cites it directly · 10 of its ownK111597 Disposable Stimulating ElectrodeNuvasive, Inc. · 2011
- Descendant · 2 generations on · 9 of its ownK112709 Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012
- Descendant · cites it directly · 9 of its ownK110419 Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine · 2011
- Descendant · 2 generations on · 5 of its ownK132373 Biomet Access SystemBiomet Spine (Aka Ebi, LLC) · 2014
- Descendant · 3 generations on · 4 of its ownK142438 Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K111597Disposable Stimulating ElectrodeNuvasive, Inc. · 2011 · cites it directly10descendants
- K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012 · 2 generations on9descendants
- K110419Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine · 2011 · cites it directly9descendants
- K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 2 generations on5descendants
- K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K980148 | Neurosign 800, 8 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1998 | — |
| −3 | K992869 | Xomed Ball-Tip Monopolar Stimulator Probe | Xomed, Inc. | 1999 | — |
| −2 | K014165 | Stimulus - Dissection Instruments | Medtronic Xomed, Inc. | 2002 | — |
| −1 | K031003 | Stimulus/Dissection Instruments, Ball-Tip Probes | Medtronic Xomed, Inc. | 2003 | 1 |
| 0 (this device) | K090838 | Stimulus/Dissection Instruments | Axon Systems, Inc. | 2009 | — |
| +1 | K111597 | Disposable Stimulating Electrode | Nuvasive, Inc. | 2011 | — |
| +2 | K112709 | Stimulation/Dissection Instruments | Nu Vasive, Incorporated | 2012 | — |
| +1 | K110419 | Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators | Stryker Spine | 2011 | — |
| +2 | K132373 | Biomet Access System | Biomet Spine (Aka Ebi, LLC) | 2014 | — |
| +3 | K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K031003 | Stimulus/Dissection Instruments, Ball-Tip ProbesSummary page 1…Procode: ETN Predicate Devices Manufacturer: Medtronic Xomed Trade Name: Stimulus Dissection Instruments FDA number: K031003 Manufacturer: Axon Systems, Inc Trade Name: Disposable Stimulator Probes… | 2003 |
| * | K062996 | Disposable Monopolar and Bipolar Stimulator ProbesSummary page 1…FDA number: K031003 Manufacturer: Axon Systems, Inc Trade Name: Disposable Stimulator Probes FDA number: K062996 Manufacturer: Nuvasive Trade Name: Surgical Nerve Stimulator/Locator… | 2007 |
| * | K002677 | Nuvasive Ins-1 Intraoperative Nerve Surveillance SystemSummary page 1…FDA number: K062996 Manufacturer: Nuvasive Trade Name: Surgical Nerve Stimulator/Locator FDA number: K002677 Appendix J… | 2000 |
What descends from it? (19)
See all 193 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 11 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K111597 (Nuvasive, Inc., 2011) has gone furthest, with 10 descendants of its own.
- 8 other devices also cite its predicate K031003.
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?
These instruments are indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090838 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090838: Stimulus/Dissection Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090838
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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