510(k) · Cleared
ClearedNeuralmas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Surgical Solutions, LLC ("Iss") · ETN Stimulator, Nerve
Cleared on Sep 24, 2010 as substantially equivalent to K031510 (Medtronic Xomed, 2003) and 3 other predicates after a 168-day review. Its family tree reaches back 5 generations to 1998. 6 later devices descend from it.
- Decided
- Sep 24, 2010
- Review
- 168 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K980148 (1998). 20 ancestors in all, the oldest K842956 (1984). 6 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 backK072736 Rhythmlink International Monopolar Stimulating InstrumentRhythmlink International, LLC · 2008 · Recalled
- This deviceK100992 NeuralmasInnovative Surgical Solutions, LLC ("Iss") · 2010
- Descendant · cites it directly · 3 of its ownK131304 Sentio MMGInnovative Surgical Solutions, LLC ("Iss") · 2014
- Descendant · 2 generations on · 2 of its ownK173526 SENTIO MMG Gen 2Medos International SARL · 2018
- Descendant · 3 generations on · 1 of its ownK243636 Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 2025
- Descendant · cites it directly · 1 of its ownK173134 SENTIO MMG Pedicle Access NeedlesMedos International SARL · 2018
- Descendant · 4 generations on · 0 of its ownK260992 iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe…Neuralytix · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K131304Sentio MMGInnovative Surgical Solutions, LLC ("Iss") · 2014 · cites it directly3descendants
- K173526SENTIO MMG Gen 2Medos International SARL · 2018 · 2 generations on2descendants
- K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 2025 · 3 generations on1descendant
- K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL · 2018 · cites it directly1descendant
- K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix · 2026 · 4 generations on0descendants
View 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 | K072736 | Rhythmlink International Monopolar Stimulating Instrument | Rhythmlink International, LLC | 2008 | 1 |
| 0 (this device) | K100992 | Neuralmas | Innovative Surgical Solutions, LLC ("Iss") | 2010 | — |
| +1 | K131304 | Sentio MMG | Innovative Surgical Solutions, LLC ("Iss") | 2014 | — |
| +2 | K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018 | — |
| +3 | K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | 2025 | — |
| +1 | K173134 | SENTIO MMG Pedicle Access Needles | Medos International SARL | 2018 | — |
| +4 | K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006)… | Neuralytix | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K031510 | Nim-SpineSummary page 3…Predicate Device: 155 NeuralMAS Medtronic NIMI-Spine #K031510 System Overview System Overview… | 2003 |
| * | K072736 | Rhythmlink International Monopolar Stimulating InstrumentSummary page 1…stantially equivalent to one or more of the following predicate devices: 1(031510 NIM-Spine, Medtronic Xomed, Jacksonville, Florida K(072736 Rhythmlink, Columbia, South Carolina K(062996 Axon Systems, Hauppauge, New York K(000722 Un… | 2008 |
| * | K062996 | Disposable Monopolar and Bipolar Stimulator ProbesSummary page 1…predicate devices: 1(031510 NIM-Spine, Medtronic Xomed, Jacksonville, Florida K(072736 Rhythmlink, Columbia, South Carolina K(062996 Axon Systems, Hauppauge, New York K(000722 UniPlex Nanolirne Cannula, Pajunk GMBH, Geisingen, Germany… | 2007 |
| * | K000722 | Unipolar NeedlesSummary page 1…dtronic Xomed, Jacksonville, Florida K(072736 Rhythmlink, Columbia, South Carolina K(062996 Axon Systems, Hauppauge, New York K(000722 UniPlex Nanolirne Cannula, Pajunk GMBH, Geisingen, Germany NeuralMAS'T m Nerve Mapping & Avoidance System === Page… | 2000 |
What descends from it? (6)
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 12 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K131304 (Innovative Surgical Solutions, LLC ("Iss"), 2014) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K031510.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves.
This device is indicated for locating and identifying spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100992 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100992: Neuralmas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100992
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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