510(k) · Cleared
ClearedNeuralytix iD3 System (NTX-9001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuralytix, LLC · PDQ Neurosurgical Nerve Locator
Cleared on Jun 26, 2025 as substantially equivalent to K173526 (Medos International SARL, 2018) after a 213-day review. Its family tree reaches back 14 generations to 1984. 1 later device descends from it.
- Decided
- Jun 26, 2025
- Review
- 213 days
- Class
- Class II
- Product code
- PDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K842956 (1984). 97 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 10 generations between
- 3 generations backK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
- 2 generations backK162313 NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017
- 1 generation backK173526 SENTIO MMG Gen 2Medos International SARL · 2018
- This deviceK243636 Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 2025
- Descendant · cites it directly · 0 of its ownK260992 iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe…Neuralytix · 2026
Show all 14 generations
- Root · 14 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 13 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 12 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 11 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 10 generations backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- 9 generations backK061113 OrthomonAxon Systems, Inc. · 2006
- 8 generations backK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- 7 generations backK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- 6 generations backK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- 5 generations backK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- 4 generations backK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
- 3 generations backK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
- 2 generations backK162313 NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017
- 1 generation backK173526 SENTIO MMG Gen 2Medos International SARL · 2018
- This deviceK243636 Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −13 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −12 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −11 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −10 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| −9 | K061113 | Orthomon | Axon Systems, Inc. | 2006 | — |
| −8 | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| −7 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| −6 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| −5 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
| −4 | K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015 | 1 |
| −3 | K152942 | NuVasiveNVM5 System | Nu Vasive, Incorporated | 2016 | — |
| −2 | K162313 | NuVasive Next Generation NVM5 System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018 | — |
| 0 (this device) | K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | 2025 | — |
| +1 | 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 |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 4 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 6 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 PDQ? 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 PDQ device
- #1 K260992 iD3 Nav Decompression Probe (NTX-9005); iD3…score 15.8 · 15 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 |
|---|---|---|---|
| * | K173526 | SENTIO MMG Gen 2Summary page 5…timulator, Nerve D. Predicate Device Name The subject Neuralytix iD3 System is substantially equivalent to the following primary predicate device: • K173526 Sentio MMG Gen 2 E. Device Description The Neuralytix iD3 System is a multichannel device for locating, mapping and asse… | 2018 |
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 |
|---|---|---|---|
| K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball… | 2026 | 0 |
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 41 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 97 ancestors have a recall of any class.
- Of its descendants, K260992 (Neuralytix, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PDQ devicesPDQ Neurosurgical Nerve Locator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PDQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDQ
182in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDQ
No recall names PDQ since 2007.
Adverse event reports per year · PDQ
2in 2025
MAUDE reports naming product code PDQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 5 | 181 | 0 | 1 |
| 2014 | 7 | 254 | 0 | 0 |
| 2015 | 3 | 95 | 0 | 1 |
| 2016 | 3 | 100 | 0 | 4 |
| 2017 | 2 | — | 0 | 5 |
| 2018 | 4 | 162 | 0 | 5 |
| 2019 | 4 | 182 | 0 | 10 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 2 | — | 0 | 10 |
| 2022 | 2 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 2 |
| 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. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status by measuring and comparing MMG signals throughout a surgical procedure. The device is intended to identify relative changes in the conduction and neural…
Read the full statement (154 words)
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. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status by measuring and comparing MMG signals throughout a surgical procedure.
The device is intended to identify relative changes in the conduction and neural transmission ability of the nerve throughout a surgical procedure by measuring and comparing the minimum amount of electrical stimulation current (mA) required to induce a measurable MMG response (MMG nerve response threshold).
Examples of surgical applications which may require mechanomyographic (MMG) monitoring:
• Minimally invasive and open spinal surgery involving spinal fusion cages, screws, rods, plates, discs and biologics.
• Minimally invasive, open and endoscopic, direct and indirect nerve decompressions, discectomies, laminectomies, laminotomies, facetectomies, foraminotomies.
• Treatment of nerve compression, stenosis, degenerative disc disease, disc herniation, spondylolisthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243636: Neuralytix iD3 System (NTX-9001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243636
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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