510(k) · Cleared
Recalled · Class II · 2021Stim Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spes Medica Srl · ETN Stimulator, Nerve
Cleared on Nov 21, 2014 as substantially equivalent to K112435 (Rhythmlink International, LLC, 2011) and 4 other predicates after a 387-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 21, 2014
- Review
- 387 days
- Class
- Class II
- Product code
- ETN
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 7 generations to K923056 (1992). 19 ancestors in all, the oldest K895676 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK923056 Neurosign Model 100The Magstim Company, Ltd. · 1992 · Recalled
- 6 generations backK991583 Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999
- 5 generations backK050325 Disposable Concentric Probe, Disposable Bipolar Probe, Disposable…Technomed Europe · 2005
- 4 generations backK062996 Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007
- 3 generations backK063729 Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007
- 2 generations backK103128 Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip…Cadwell Lab, Inc. · 2011
- 1 generation backK112426 Xian Friendship Disposable Nerve Stimulator ProbesXian Friendship Medical Electronics Co., Ltd. · 2012
- This deviceK133348 Stim ProbeSpes Medica Srl · 2014
- Descendant · cites it directly · 0 of its ownK152769 Fremap ElectrodeAd-Tech Medical Instrument Corporation · 2016
Most influential descendants
Showing 1 of 1 · See all- K152769Fremap ElectrodeAd-Tech Medical Instrument Corporation · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K923056 | Neurosign Model 100 | The Magstim Company, Ltd. | 1992 | 1 |
| −6 | K991583 | Neurosign 400, 4 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1999 | — |
| −5 | K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar… | Technomed Europe | 2005 | — |
| −4 | K062996 | Disposable Monopolar and Bipolar Stimulator Probes | Axon Systems, Inc. | 2007 | — |
| −3 | K063729 | Disposable Pedicle Screw Probe, Model 3603-00 | Technomed Europe | 2007 | — |
| −2 | K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip… | Cadwell Lab, Inc. | 2011 | — |
| −1 | K112426 | Xian Friendship Disposable Nerve Stimulator Probes | Xian Friendship Medical Electronics Co., Ltd. | 2012 | — |
| 0 (this device) | K133348 | Stim Probe | Spes Medica Srl | 2014 | — |
| +1 | K152769 | Fremap Electrode | Ad-Tech Medical Instrument Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K112435 | Rhythmlink Monopolar Stimulating InstrumentSummary page 4…RHYTHMLINK Monopolar RHYTHMLINK Stimulator Nerve K112435 stimulating instrument INTERNATIONAL, LLC… | 2011 |
| * | K110712 | Drytouch Suction Stimulator ProbeSummary page 4…NEUROVISION MEDICAL Drytouch Suction Stimulator probe Stimulator Nerve K110712 PRODUCTS, INC.… | 2011 |
| * | K112426 | Xian Friendship Disposable Nerve Stimulator ProbesSummary page 4…XIAN FRIENDSHIP XIAN FRIENDSHIP MEDICAL nerve Stimulator Nerve MEDICAL ELECTRONICS K112426 stimulator probes CO., LTD. SURGICAL ST… | 2012 |
| * | K110422 | Surgical StimulatorsSummary page 4…CO., LTD. SURGICAL STIMULATORS Stimulator Nerve TECHNOMED EUROPE K110422 STIMULUS/DISSECTION MEDTRONIC XOMED, St… | 2011 |
| * | K031003 | Stimulus/Dissection Instruments, Ball-Tip ProbesSummary page 4…TIMULUS/DISSECTION MEDTRONIC XOMED, Stimulator Nerve K031003 INSTRUMENTS, BALL-TIP PROBES INC Section 9… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152769 | Fremap Electrode | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2021 | Class II | Z-1971-2021 | Material/Component Contamination | The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K152769 (Ad-Tech Medical Instrument Corporation, 2016) has gone furthest, with 0 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. 2014, 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?
IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identitY nerves and spinal nerve roots and to assess nerve function. 10M Stimulator Probes disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral nerves for location and identification during surgery, including spinal nerve roots.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133348 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133348: Stim Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133348
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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