510(k) · Cleared
ClearedCadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cadwell Lab, Inc. · ETN Stimulator, Nerve
Cleared on Feb 23, 2011 as substantially equivalent to K050325 (Technomed Europe, 2005) and 6 other predicates after a 121-day review. Its family tree reaches back 5 generations to 1992. 17 later devices descend from it.
- Decided
- Feb 23, 2011
- Review
- 121 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 5 generations to K923056 (1992). 11 ancestors in all. 17 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK923056 Neurosign Model 100The Magstim Company, Ltd. · 1992 · Recalled
- 4 generations backK991583 Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999
- 3 generations backK050325 Disposable Concentric Probe, Disposable Bipolar Probe, Disposable…Technomed Europe · 2005
- 2 generations backK062996 Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007
- 1 generation backK063729 Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007
- This deviceK103128 Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip…Cadwell Lab, Inc. · 2011
- 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 · 5 of its ownK132373 Biomet Access SystemBiomet Spine (Aka Ebi, LLC) · 2014
- Descendant · 2 generations on · 4 of its ownK142438 Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015
- Descendant · 3 generations on · 3 of its ownK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K111597Disposable Stimulating ElectrodeNuvasive, Inc. · 2011 · cites it directly10descendants
- K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012 · 2 generations on9descendants
- K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC) · 2014 · cites it directly5descendants
- K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015 · 2 generations on4descendants
- K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K923056 | Neurosign Model 100 | The Magstim Company, Ltd. | 1992 | 1 |
| −4 | K991583 | Neurosign 400, 4 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1999 | — |
| −3 | K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar… | Technomed Europe | 2005 | — |
| −2 | K062996 | Disposable Monopolar and Bipolar Stimulator Probes | Axon Systems, Inc. | 2007 | — |
| −1 | K063729 | Disposable Pedicle Screw Probe, Model 3603-00 | Technomed Europe | 2007 | — |
| 0 (this device) | K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip… | Cadwell Lab, Inc. | 2011 | — |
| +1 | K111597 | Disposable Stimulating Electrode | Nuvasive, Inc. | 2011 | — |
| +2 | K112709 | Stimulation/Dissection Instruments | Nu Vasive, Incorporated | 2012 | — |
| +1 | K132373 | Biomet Access System | Biomet Spine (Aka Ebi, LLC) | 2014 | — |
| +2 | K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | 2015 | — |
| +3 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar ProbeSummary page 1…Class 11, 21 CFR 874.1820 Product Code: GXZ, ETN Classification Panel: Ear, Nose and Throat Predicate Device: Technomed.............. K050325 Technomed .............. K063729 Axon ..................... K062996… | 2005 |
| * | K063729 | Disposable Pedicle Screw Probe, Model 3603-00Summary page 1…GXZ, ETN Classification Panel: Ear, Nose and Throat Predicate Device: Technomed.............. K050325 Technomed .............. K063729 Axon ..................... K062996 XOMED................. K992869… | 2007 |
| * | K062996 | Disposable Monopolar and Bipolar Stimulator ProbesSummary page 1…dicate Device: Technomed.............. K050325 Technomed .............. K063729 Axon ..................... K062996 XOMED................. K992869 XLTEK .................. K062549… | 2007 |
| * | K992869 | Xomed Ball-Tip Monopolar Stimulator ProbeSummary page 1…Technomed .............. K063729 Axon ..................... K062996 XOMED................. K992869 XLTEK .................. K062549 Medtronic Xomed....... K03 1003… | 1999 |
| * | K062549 | Xltek Stimulator Probes, Models 105233, 105234, 105235, 105236, 105237 and 105238Summary page 1…Axon ..................... K062996 XOMED................. K992869 XLTEK .................. K062549 Medtronic Xomed....... K03 1003 Medtronic Xomed.......1K014165 Substantial… | 2006 |
| * | K031003 | Stimulus/Dissection Instruments, Ball-Tip ProbesSummary page 1…6 XOMED................. K992869 XLTEK .................. K062549 Medtronic Xomed....... K03 1003 Medtronic Xomed.......1K014165 Substantial Equivalence: The following device characteristics were c… | 2003 |
| * | K014165 | Stimulus - Dissection InstrumentsSummary page 1…XLTEK .................. K062549 Medtronic Xomed....... K03 1003 Medtronic Xomed.......1K014165 Substantial Equivalence: The following device characteristics were compared for substantial equival… | 2002 |
What descends from it? (17)
See all 175 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 19 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K111597 (Nuvasive, Inc., 2011) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K050325.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Cadwell Disposable Stimulator Probe is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.
The Cadwell Disposable Stimulator Probe is a single patient use device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103128: Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw 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/K103128
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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