510(k) · Cleared
ClearedC2 Nervemonitor System with Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inomed Medizintechnik GmbH · GWF Stimulator, Electrical, Evoked Response
Cleared on Oct 6, 2011 as substantially equivalent to K083124 (Medtronic Xomed, Inc., 2009) and 5 other predicates after a 115-day review. Its family tree reaches back 5 generations to 1998. 2 later devices descend from it.
- Decided
- Oct 6, 2011
- Review
- 115 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K980148 (1998). 20 ancestors in all, the oldest K842956 (1984). 2 later devices descend from it, 1 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 backK031510 Nim-SpineMedtronic Xomed · 2003
- 1 generation backK083124 NIM 3.0Medtronic Xomed, Inc. · 2009 · Recalled
- This deviceK111647 C2 Nervemonitor System with AccessoriesInomed Medizintechnik GmbH · 2011
- Descendant · cites it directly · 1 of its ownK152505 C2 NerveMonitor SystemInomed Medizintechnik GmbH · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK223254 C2 XploreInomed Medizintechnik GmbH · 2023
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 |
|---|---|---|---|---|---|
| −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 | K031510 | Nim-Spine | Medtronic Xomed | 2003 | — |
| −1 | K083124 | NIM 3.0 | Medtronic Xomed, Inc. | 2009 | 3 |
| 0 (this device) | K111647 | C2 Nervemonitor System with Accessories | Inomed Medizintechnik GmbH | 2011 | — |
| +1 | K152505 | C2 NerveMonitor System | Inomed Medizintechnik GmbH | 2016 | 2 |
| +2 | K223254 | C2 Xplore | Inomed Medizintechnik GmbH | 2023 | — |
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 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2023 | 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 GWF? 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 GWF device
- #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K083124 | NIM 3.0Summary page 1…gally Marketed Equivalent Device Company Product 510(k) # Medtronic Xomed Nerve Integrity Monitor 3.0 K083124 Magstim Nerve Avalanche Thyroid/EMG Motor K083242 Nerve Monitor Magstim… | 2009 |
| * | K083242 | Neurosign Avalanche Motor Nerve MonitorSummary page 1…uct 510(k) # Medtronic Xomed Nerve Integrity Monitor 3.0 K083124 Magstim Nerve Avalanche Thyroid/EMG Motor K083242 Nerve Monitor Magstim Neurosign 400 Motor Nerve Monitor K991583 Medtronic Xome… | 2009 |
| * | K991583 | Neurosign 400, 4 Channel Motor Nerve MonitorSummary page 1…Nerve Avalanche Thyroid/EMG Motor K083242 Nerve Monitor Magstim Neurosign 400 Motor Nerve Monitor K991583 Medtronic Xomed Xomed Bali-Tip Monopolar Stimulation probe K992869 Magsti… | 1999 |
| * | K992869 | Xomed Ball-Tip Monopolar Stimulator ProbeSummary page 1…Neurosign 400 Motor Nerve Monitor K991583 Medtronic Xomed Xomed Bali-Tip Monopolar Stimulation probe K992869 Magstim Neurosign 800. 8 Channel Motor Nerve Monitor with accessories K980148 M… | 1999 |
| * | K980148 | Neurosign 800, 8 Channel Motor Nerve MonitorSummary page 1…Stimulation probe K992869 Magstim Neurosign 800. 8 Channel Motor Nerve Monitor with accessories K980148 Magstim Neurosign 600 Motor Motor Nerve Monitor with accessories K964869… | 1998 |
| * | K964869 | Neurosign 800, 8 Channel Motor Nerve MonitorSummary page 1…Nerve Monitor with accessories K980148 Magstim Neurosign 600 Motor Motor Nerve Monitor with accessories K964869 Section / Page 5-2 DEVICE DESCRIPTION… | 1997 |
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 |
|---|---|---|---|
| K152505 | C2 NerveMonitor System | 2016 | 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 13 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K152505 (Inomed Medizintechnik GmbH, 2016) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K083124.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWF
92in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWF
1,034in 2025
MAUDE reports naming product code GWF, 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 | 3 | 69 | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 5 | 178 | 0 | 1 |
| 2010 | 3 | 269 | 0 | 4 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 4 | 230 | 1 | 44 |
| 2013 | 3 | 174 | 0 | 89 |
| 2014 | 1 | — | 0 | 25 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 1 | — | 0 | 20 |
| 2017 | 3 | 169 | 0 | 60 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 94 |
| 2020 | 1 | — | 0 | 65 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 2 | — | 0 | 45 |
| 2023 | 2 | — | 0 | 150 |
| 2024 | 4 | 92 | 0 | 854 |
| 2025 | 1 | — | 0 | 1,034 |
| 2026 | 3 | 125 | 2 | — |
What is it indicated for?
The 02 NerveMonitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal cord and spinal nerve roots. The 02 NerveMonitor device with the integrated user interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical…
Read the full statement (156 words)
The 02 NerveMonitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal cord and spinal nerve roots. The 02 NerveMonitor device with the integrated user interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device
Indications for 02 NerveMonitor System Monitoring Procedures include:
Intracranial, Extracranial, Intratemporai, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities.
Indications for 02 NerveMonitor System monitoring of Spinal procedures include:
Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures and Thoracic Surgical Procedures.
The system is not intended for monitoring life preserving functions.
The system may not be used for diagnosing brain death.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111647: C2 Nervemonitor System with Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111647
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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