510(k) · Cleared
ClearedSENTIO MMG Gen 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · PDQ Neurosurgical Nerve Locator
Cleared on Apr 5, 2018 as substantially equivalent to K131304 (Innovative Surgical Solutions, LLC ("Iss"), 2014) and 2 other predicates after a 142-day review. Its family tree reaches back 13 generations to 1984. 2 later devices descend from it.
- Decided
- Apr 5, 2018
- Review
- 142 days
- Class
- Class II
- Product code
- PDQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K842956 (1984). 96 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 9 generations between
- 3 generations backK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
- 2 generations backK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
- 1 generation backK162313 NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017
- This deviceK173526 SENTIO MMG Gen 2Medos International SARL · 2018
- Descendant · cites it directly · 1 of its ownK243636 Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK260992 iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe…Neuralytix · 2026
Show all 13 generations
- Root · 13 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 12 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 11 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 10 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 9 generations backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- 8 generations backK061113 OrthomonAxon Systems, Inc. · 2006
- 7 generations backK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- 6 generations backK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- 5 generations backK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- 4 generations backK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- 3 generations backK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
- 2 generations backK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
- 1 generation backK162313 NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017
- This deviceK173526 SENTIO MMG Gen 2Medos International SARL · 2018
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 |
|---|---|---|---|---|---|
| −13 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −12 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −11 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −10 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −9 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| −8 | K061113 | Orthomon | Axon Systems, Inc. | 2006 | — |
| −7 | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| −6 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| −5 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| −4 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
| −3 | K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015 | 1 |
| −2 | K152942 | NuVasiveNVM5 System | Nu Vasive, Incorporated | 2016 | — |
| −1 | K162313 | NuVasive Next Generation NVM5 System | Nu Vasive, Incorporated | 2017 | — |
| 0 (this device) | K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018 | — |
| +1 | K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | 2025 | — |
| +2 | 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 |
|---|---|---|
| 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 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 K243636 Neuralytix iD3 System (NTX-9001)score 16.5 · 14 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 |
|---|---|---|---|
| * | K131304 | Sentio MMGSummary page 4…Description: PDQ; Neurosurgical Nerve Locator ETN; Stimulator, Nerve D. Predicate Device Name Primary: SENTIO MMG (K131304) Other: NuVasive Next Generation NVM5 System (K162313), STIMPOD NMS450 Nerve Stimulator (K102084)… | 2014 |
| * | K162313 | NuVasive Next Generation NVM5 SystemSummary page 4…ETN; Stimulator, Nerve D. Predicate Device Name Primary: SENTIO MMG (K131304) Other: NuVasive Next Generation NVM5 System (K162313), STIMPOD NMS450 Nerve Stimulator (K102084) Reference NIM-Spine (K031510), predicate to original SEN… | 2017 |
| * | K102084 | Stimpod NMS450 Nerve StimulatorSummary page 4…ice Name Primary: SENTIO MMG (K131304) Other: NuVasive Next Generation NVM5 System (K162313), STIMPOD NMS450 Nerve Stimulator (K102084) Reference NIM-Spine (K031510), predicate to original SENTIO MMG Device: submission (K100992)… | 2010 |
| † | K031510 | Nim-Spine | 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 |
|---|---|---|---|
| K243636 | Neuralytix iD3 System (NTX-9001) | 2025 | 1 |
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 34 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 12 of the 96 ancestors have a recall of any class.
- Of its descendants, K243636 (Neuralytix, LLC, 2025) has gone furthest, with 1 descendant 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. 2018, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173526: SENTIO MMG Gen 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173526
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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