510(k) · Cleared
ClearedDrytouch Suction Stimulator Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurovision Medical Products, Inc. · ETN Stimulator, Nerve
Cleared on Jun 28, 2011 as substantially equivalent to K895676 (Rln Systems, Inc., 1989) and 1 other predicate after a 106-day review. Its family tree reaches back 5 generations to 1998. 3 later devices descend from it.
- Decided
- Jun 28, 2011
- Review
- 106 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K980148 (1998). 12 ancestors in all, the oldest K895676 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK980148 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1998
- 4 generations backK992869 Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 1999
- 3 generations backK014165 Stimulus - Dissection InstrumentsMedtronic Xomed, Inc. · 2002
- 2 generations backK031003 Stimulus/Dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc. · 2003 · Recalled
- 1 generation backK090838 Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009
- This deviceK110712 Drytouch Suction Stimulator ProbeNeurovision Medical Products, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK133348 Stim ProbeSpes Medica Srl · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK212164 Mapping Suction ProbeInomed Medizintechnik GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK152769 Fremap ElectrodeAd-Tech Medical Instrument Corporation · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K980148 | Neurosign 800, 8 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1998 | — |
| −4 | K992869 | Xomed Ball-Tip Monopolar Stimulator Probe | Xomed, Inc. | 1999 | — |
| −3 | K014165 | Stimulus - Dissection Instruments | Medtronic Xomed, Inc. | 2002 | — |
| −2 | K031003 | Stimulus/Dissection Instruments, Ball-Tip Probes | Medtronic Xomed, Inc. | 2003 | 1 |
| −1 | K090838 | Stimulus/Dissection Instruments | Axon Systems, Inc. | 2009 | — |
| 0 (this device) | K110712 | Drytouch Suction Stimulator Probe | Neurovision Medical Products, Inc. | 2011 | — |
| +1 | K133348 | Stim Probe | Spes Medica Srl | 2014 | 1 |
| +1 | K212164 | Mapping Suction Probe | Inomed Medizintechnik GmbH | 2022 | — |
| +2 | 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 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K895676 | Hemostat/Stimulator ProbeSummary page 1…vision Medical Products Inc. Device Name: Hemostat/Stimulator Probe (SHEM-s) 510K Number: K895676 Manufacturer: Axon Systems, Inc. Device Name: XPA… | 1989 |
| * | K090838 | Stimulus/Dissection InstrumentsSummary page 1…Manufacturer: Axon Systems, Inc. Device Name: XPAK 11 510K Number: K090838 Device Description The Suction Stimulator Probe is a disposable, single use, sterile instrument that combines concurrent… | 2009 |
| * | — | Frazier Suction Coagulator (part #23-5001) Named without a submission number |
What descends from it? (3)
2 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 13 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K133348 (Spes Medica Srl, 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K895676.
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 Suction Stimulator Probe is a dedicated manual surgical instrument that allows the surgeon to clear secretions and test surgical tissue with nerve stimulation at the same time and with the same instrument. It is intended for use only by a licensed physician and in conjunction with the Neurovision SE (Nerveina) Nerve locator Monitor System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110712: Drytouch Suction 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/K110712
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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