510(k) · Cleared
ClearedXomed Ball-Tip Monopolar Stimulator Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · ETN Stimulator, Nerve
Cleared on Oct 7, 1999 as substantially equivalent to K980148 (The Magstim Company, Ltd., 1998) after a 43-day review. Its family tree reaches back 1 generation to 1998. 2 of the 486 devices in its family, counting itself, have a Class I recall. 484 later devices descend from it.
- Decided
- Oct 7, 1999
- Review
- 43 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980148 (1998). 484 later devices descend from it, 7 citing it directly. 2 of the 486 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK980148 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1998
- This deviceK992869 Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 1999
- Descendant · cites it directly · 424 of its ownK063305 Stimulating Bur GuardMedtronic Xomed, Inc. · 2006
- Descendant · 2 generations on · 418 of its ownK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 404 of its ownK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 398 of its ownK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · 3 generations on · 396 of its ownK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
Showing 5 of 484 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 484 · See all- K063305Stimulating Bur GuardMedtronic Xomed, Inc. · 2006 · cites it directly424descendants
- K111520Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · 2 generations on418descendants
- K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc. · 2013 · 3 generations on404descendants
- K123270Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013 · 3 generations on398descendants
- K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · 3 generations on396descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980148 | Neurosign 800, 8 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1998 | — |
| 0 (this device) | K992869 | Xomed Ball-Tip Monopolar Stimulator Probe | Xomed, Inc. | 1999 | — |
| +1 | K063305 | Stimulating Bur Guard | Medtronic Xomed, Inc. | 2006 | — |
| +2 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| +3 | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | Medtronic Navigation, Inc. | 2013 | 1 |
| +3 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +3 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 9 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 10 | 0 |
| 2017 | 15 | 0 |
| 2018 | 22 | 0 |
| 2019 | 30 | 0 |
| 2020 | 23 | 1 |
| 2021 | 42 | 1 |
| 2022 | 50 | 0 |
| 2023 | 69 | 0 |
| 2024 | 61 | 0 |
| 2025 | 62 | 0 |
| 2026 | 58 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | K980148 | Neurosign 800, 8 Channel Motor Nerve MonitorSummary page 1…oots. 8.0 Substantial Equivalence The Xomed Ball-Tip Monopolar Stimulator Probe is substantially equivalent to the Magstim/Neurosign Pedicle Hole Probe as described in K980148 in its intended use, materials, and overall design. "' l'l"%'b 5 _-/é DEPARTMENT OF HEALTH & HUMAN SERVICES Publ… | 1998 |
What descends from it? (484)
See all 4847 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063305 | Stimulating Bur Guard | 2006 | 424 |
| K014165 | Stimulus - Dissection Instruments | 2002 | 65 |
| K031003 | Stimulus/Dissection Instruments, Ball-Tip Probes | 2003 | 35 |
| K062996 | Disposable Monopolar and Bipolar Stimulator Probes | 2007 | 32 |
| K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw… | 2011 | 17 |
| K111647 | C2 Nervemonitor System with Accessories | 2011 | 2 |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM… | 2022 | 1 |
Has anything in its family been recalled? (2 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.
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?
The Ball-Tip Monopolar Stimulating Probe is intended to stimulate 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/K992869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992869: Xomed Ball-Tip Monopolar Stimulator Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992869
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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