510(k) · Cleared
ClearedXltek Stimulator Probes, Models 105233, 105234, 105235, 105236, 105237 and 105238
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excel Tech., Ltd. · ETN Stimulator, Nerve
Cleared on Oct 4, 2006 after a 35-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 18 later devices descend from it.
- Decided
- Oct 4, 2006
- Review
- 35 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK062549 Xltek Stimulator Probes, Models 105233, 105234, 105235, 105236…Excel Tech., Ltd. · 2006
- Descendant · cites it directly · 17 of its ownK103128 Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip…Cadwell Lab, Inc. · 2011
- Descendant · 2 generations on · 10 of its ownK111597 Disposable Stimulating ElectrodeNuvasive, Inc. · 2011
- Descendant · 3 generations on · 9 of its ownK112709 Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012
- 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 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…Cadwell Lab, Inc. · 2011 · cites it directly17descendants
- K111597Disposable Stimulating ElectrodeNuvasive, Inc. · 2011 · 2 generations on10descendants
- K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012 · 3 generations on9descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K062549 | Xltek Stimulator Probes, Models 105233, 105234, 105235, 105236, 105237 and… | Excel Tech., Ltd. | 2006 | — |
| +1 | K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip… | Cadwell Lab, Inc. | 2011 | — |
| +2 | K111597 | Disposable Stimulating Electrode | Nuvasive, Inc. | 2011 | — |
| +3 | K112709 | Stimulation/Dissection Instruments | Nu Vasive, Incorporated | 2012 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw… | 2011 | 17 |
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?
- Of its descendants, K103128 (Cadwell Lab, Inc., 2011) has gone furthest, with 17 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?
The XLTEK Stimulator Probes are intended to stimulate cranial and peripheral motor
nerves for location and identification during surgery, including spinal nerve roots.
The probes are sterile and are for single patient use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K062549 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062549: Xltek Stimulator Probes, Models 105233, 105234, 105235, 105236, 105237 and 105238.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062549
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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