510(k) · Cleared
ClearedSentio MMG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Surgical Solutions, LLC ("Iss") · PDQ Neurosurgical Nerve Locator
Cleared on May 29, 2014 as substantially equivalent to K100992 (Innovative Surgical Solutions, LLC ("Iss"), 2010) after a 387-day review. Its family tree reaches back 6 generations to 1998. 3 later devices descend from it.
- Decided
- May 29, 2014
- Review
- 387 days
- Class
- Class II
- Product code
- PDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K980148 (1998). 21 ancestors in all, the oldest K842956 (1984). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK980148 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1998
- 5 generations backK992869 Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 1999
- 4 generations backK014165 Stimulus - Dissection InstrumentsMedtronic Xomed, Inc. · 2002
- 3 generations backK031003 Stimulus/Dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc. · 2003 · Recalled
- 2 generations backK072736 Rhythmlink International Monopolar Stimulating InstrumentRhythmlink International, LLC · 2008 · Recalled
- 1 generation backK100992 NeuralmasInnovative Surgical Solutions, LLC ("Iss") · 2010
- This deviceK131304 Sentio MMGInnovative Surgical Solutions, LLC ("Iss") · 2014
- Descendant · cites it directly · 2 of its ownK173526 SENTIO MMG Gen 2Medos International SARL · 2018
- Descendant · 2 generations on · 1 of its ownK243636 Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK260992 iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe…Neuralytix · 2026
Most influential descendants
Showing 3 of 3 · See all- K173526SENTIO MMG Gen 2Medos International SARL · 2018 · cites it directly2descendants
- K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 2025 · 2 generations on1descendant
- K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K980148 | Neurosign 800, 8 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1998 | — |
| −5 | K992869 | Xomed Ball-Tip Monopolar Stimulator Probe | Xomed, Inc. | 1999 | — |
| −4 | K014165 | Stimulus - Dissection Instruments | Medtronic Xomed, Inc. | 2002 | — |
| −3 | K031003 | Stimulus/Dissection Instruments, Ball-Tip Probes | Medtronic Xomed, Inc. | 2003 | 1 |
| −2 | K072736 | Rhythmlink International Monopolar Stimulating Instrument | Rhythmlink International, LLC | 2008 | 1 |
| −1 | K100992 | Neuralmas | Innovative Surgical Solutions, LLC ("Iss") | 2010 | — |
| 0 (this device) | K131304 | Sentio MMG | Innovative Surgical Solutions, LLC ("Iss") | 2014 | — |
| +1 | K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018 | — |
| +2 | K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | 2025 | — |
| +3 | 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 |
|---|---|---|
| 2018 | 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 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? (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 |
|---|---|---|---|
| * | K100992 | NeuralmasSummary page 1…ocator/Stimulator 4. Predicate Device Information: The subject device Sentio MMG®1 is substantially equivalent to the following predicate device: K100992 NeuraMASTM, Innovative Surgical Solutions, LLC d/b/a Sentio, LLC, Wixom, Michigan… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173526 | SENTIO MMG Gen 2 | 2018 | 2 |
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 16 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K173526 (Medos International SARL, 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K100992.
How does its category compare?
All PDQ devicesPDQ Neurosurgical Nerve Locator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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. 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/K131304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131304: Sentio MMG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131304
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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