510(k) Report

510(k) · Cleared

Recalled · 2008

Stimulus/Dissection Instruments, Ball-Tip Probes

K031003510(k) SpecialCleared Apr 11, 200311-day reviewClass II21 CFR 874.1820Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Xomed, Inc. · ETN Stimulator, Nerve

Cleared on Apr 11, 2003 as substantially equivalent to K014165 (Medtronic Xomed, Inc., 2002) and 1 other predicate after an 11-day review. Its family tree reaches back 3 generations to 1998. 35 later devices descend from it. It has been recalled once.

Decided
Apr 11, 2003
Review
11 days
Class
Class II
Product code
ETN
Recalls
1
Predicates
2

Its longest line of descent runs back 3 generations to K980148 (1998). 35 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2011: 5 descendants cleared2012: 3 descendants cleared2009: 1 descendant cleared2014: 5 descendants cleared2008: 1 descendant cleared2018: 3 descendants cleared2016: 2 descendants cleared2010: 1 descendant cleared2023: 4 descendants cleared2019: 3 descendants cleared2022: 2 descendants cleared2015: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 2 descendants clearedK980148 · Neurosign 800, 8 Channel Motor Nerve Monitor · The Magstim Company, Ltd. · 1998K992869 · Xomed Ball-Tip Monopolar Stimulator Probe · Xomed, Inc. · 1999K014165 · Stimulus - Dissection Instruments · Medtronic Xomed, Inc. · 20021995200020052010201520202025
Descendants, by generation 1 generation forward: 9 descendants2 generations forward: 11 descendants3 generations forward: 7 descendants4 generations forward: 4 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K014165 · Stimulus - Dissection Instruments · Medtronic Xomed, Inc. · 2002K992869 · Xomed Ball-Tip Monopolar Stimulator Probe · Xomed, Inc. · 1999K980148 · Neurosign 800, 8 Channel Motor Nerve Monitor · The Magstim Company, Ltd. · 19980+5
  1. Root · 3 generations backK980148 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1998
  2. 2 generations backK992869 Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 1999
  3. 1 generation backK014165 Stimulus - Dissection InstrumentsMedtronic Xomed, Inc. · 2002
  4. This deviceK031003 Stimulus/Dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc. · 2003
  5. Descendant · cites it directly · 19 of its ownK090838 Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009
  6. Descendant · cites it directly · 17 of its ownK103128 Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip…Cadwell Lab, Inc. · 2011
  7. Descendant · cites it directly · 10 of its ownK111597 Disposable Stimulating ElectrodeNuvasive, Inc. · 2011
  8. Descendant · cites it directly · 9 of its ownK112709 Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012
  9. Descendant · 2 generations on · 9 of its ownK110419 Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine · 2011

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 12011: 52012: 32014: 52015: 12016: 22018: 32019: 32022: 22023: 42024: 12025: 12026: 2
2008high 5 (2011) · low 0 (2013)2026

Most influential descendants

Showing 5 of 35 · See all
  • K090838Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009 · cites it directly19descendants
  • K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…Cadwell Lab, Inc. · 2011 · cites it directly17descendants
  • K111597Disposable Stimulating ElectrodeNuvasive, Inc. · 2011 · cites it directly10descendants
  • K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012 · cites it directly9descendants
  • K110419Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine · 2011 · 2 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K980148Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd.1998—
−2K992869Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc.1999—
−1K014165Stimulus - Dissection InstrumentsMedtronic Xomed, Inc.2002—
0 (this device)K031003Stimulus/Dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc.2003—
+1K090838Stimulus/Dissection InstrumentsAxon Systems, Inc.2009—
+1K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip…Cadwell Lab, Inc.2011—
+1K111597Disposable Stimulating ElectrodeNuvasive, Inc.2011—
+1K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated2012—
+2K110419Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201010
201150
201230
201450
201510
201620
201830
201930
202220
202340
202410
202510
202620
FIG. 1 — Lineage of K031003, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251672 NIM Essence™ EMG Endotracheal Tube…score 12.3 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K014165Stimulus - Dissection InstrumentsMedtronic Xomed, Inc.2002—
*K992869Xomed Ball-Tip Monopolar Stimulator Probe
Summary page 2
…tiallyequivalent to Medtronic Xomed Stimulus Dissection Instruments cleared via KO14 165 and Medtronic Xomed Monopolar Stimulator Probes originally described in K992869. Characteristic Stimulus - Dissection Stimulus / Dissection Instruments…
Xomed, Inc.1999—

Also cleared against K014165: 3 other devices →

What descends from it? (35)

See all 35

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090838Stimulus/Dissection InstrumentsAxon Systems, Inc.200919
K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…Cadwell Lab, Inc.201117
K111597Disposable Stimulating ElectrodeNuvasive, Inc.201110
K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated20129
K072736Rhythmlink International Monopolar Stimulating InstrumentRhythmlink International, LLC20088
K112426Xian Friendship Disposable Nerve Stimulator ProbesXian Friendship Medical Electronics Co., Ltd.20122
K110422Surgical StimulatorsTechnomed Europe20112
K180542NIM PAK Needle; NIM XPAK Needle; NIM Pedicle ProbeBoston Endo Surgical Tech,20181
K133348Stim ProbeSpes Medica Srl20141

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 21, 2008Not classifiedZ-0947-2009Employee errorDevice may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K090838 (Axon Systems, Inc., 2009) has gone furthest, with 19 descendants of its own.
  • 3 other devices also cite its predicate K014165.

How does its category compare?

All ETN devices

ETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ETN

1in 2025

2007: 22008: 22009: 52010: 32011: 92012: 72013: 12014: 22015: 12016: 22020: 12021: 12022: 22023: 52024: 22025: 12026 (partial year): 2
2007high 9 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ETN

98in 2023

2009: 115 days median2010: 168 days median2011: 115 days median2012: 179 days median2023: 98 days median
2007high 179 (2012) · low 98 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ETN

1in 2023

2008: 12010: 12016: 12019: 22020: 12021: 12023: 1
2007high 2 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ETN

1,145in 2025

2007: 52008: 52009: 222010: 262011: 552012: 1872013: 2702014: 1372015: 2022016: 1452017: 1172018: 2502019: 3142020: 2382021: 1972022: 2472023: 3902024: 7482025: 1,145
2007high 1,145 (2025) · low 5 (2007)2025

MAUDE reports naming product code ETN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—05
20082—15
20095115022
20103168126
20119115055
201271790187
20131—0270
20142—0137
20151—0202
20162—1145
20170—0117
20180—0250
20190—2314
20201—1238
20211—1197
20222—0247
20235981390
20242—0748
20251—01,145
20262—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 as stated in the FDA summary.

Also cleared against K014165

3 other devices cite the same predicate.

  • K111671Seaspine Monopolar Probe SysyemSeaspine, Inc. · 2011
  • K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe,Cadwell Lab, Inc. · 2011
  • K031510Nim-SpineMedtronic Xomed · 2003

More from Medtronic Xomed, Inc.

47 FDA decisions under this applicant name. See the company

  • K262235ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking…Medtronic Xomed, Inc. · 2026
  • K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™…Medtronic Xomed, Inc. · 2026
  • K230320NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeMedtronic Xomed, Inc. · 2023
  • K231580NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)Medtronic Xomed, Inc. · 2023
  • K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe…Medtronic Xomed, Inc. · 2022

Recent decisions in ETN

The ETN category page

  • K253536Evala Nerve Stimulator (EPNR002)Epineuron Technologies, Inc. · 2026
  • K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™…Medtronic Xomed, Inc. · 2026
  • K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3…Inomed Medizintechnik GmbH · 2025
  • K233001Bioscope Neuromonitor DeviceBiosys Biyomedikal Muhendislik San. VE Tic. A.S. · 2024
  • K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLC · 2024

https://510kreport.com/device/K031003 · printed Nov 4, 2026

Cite this page

510(k) Report. “K031003: Stimulus/Dissection Instruments, Ball-Tip Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031003

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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