510(k) · Cleared
Recalled · Class II · 2024Surgical Stimulators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technomed Europe · ETN Stimulator, Nerve
Cleared on May 26, 2011 as substantially equivalent to K031003 (Medtronic Xomed, Inc., 2003) after a 101-day review. Its family tree reaches back 4 generations to 1998. 2 later devices descend from it. It has been recalled once.
- Decided
- May 26, 2011
- Review
- 101 days
- Class
- Class II
- Product code
- ETN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K980148 (1998). 2 later devices descend from it, 1 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 deviceK110422 Surgical StimulatorsTechnomed Europe · 2011
- Descendant · cites it directly · 1 of its ownK133348 Stim ProbeSpes Medica Srl · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK152769 Fremap ElectrodeAd-Tech Medical Instrument Corporation · 2016
Most influential descendants
Showing 2 of 2 · See allView 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) | K110422 | Surgical Stimulators | Technomed Europe | 2011 | — |
| +1 | K133348 | Stim Probe | Spes Medica Srl | 2014 | 1 |
| +2 | K152769 | Fremap Electrode | Ad-Tech Medical Instrument Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K031003 | Stimulus/Dissection Instruments, Ball-Tip ProbesSummary page 1…: Surgical nerve stimulator/locator is classified as class 11 per 21 CER section 874.1820. Product code ETN. Substantial Equivalence: K03 1003: Medtronic Xomed Stimulus/Dissection Instruments, Ball-Tip Probes Device description: Kartush… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133348 | Stim Probe | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 25, 2024 | Class II | Z-3131-2024 | Process control | Product has have presence of brown discoloration or substance on the hinge area of the device |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K133348 (Spes Medica Srl, 2014) has gone furthest, with 1 descendant 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. 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?
The Kartush disposable surgical stimulators 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.
https://510kreport.com/device/K110422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110422: Surgical Stimulators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110422
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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