510(k) · Cleared
Recalled · Class II · 2019C2 NerveMonitor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inomed Medizintechnik GmbH · ETN Stimulator, Nerve
Cleared on Feb 1, 2016 as substantially equivalent to K111647 (Inomed Medizintechnik GmbH, 2011) after a 152-day review. Its family tree reaches back 6 generations to 1998. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Feb 1, 2016
- Review
- 152 days
- Class
- Class II
- Product code
- ETN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K980148 (1998). 21 ancestors in all, the oldest K842956 (1984). 1 later device descends 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 backK031510 Nim-SpineMedtronic Xomed · 2003
- 2 generations backK083124 NIM 3.0Medtronic Xomed, Inc. · 2009 · Recalled
- 1 generation backK111647 C2 Nervemonitor System with AccessoriesInomed Medizintechnik GmbH · 2011
- This deviceK152505 C2 NerveMonitor SystemInomed Medizintechnik GmbH · 2016
- Descendant · cites it directly · 0 of its ownK223254 C2 XploreInomed Medizintechnik GmbH · 2023
Most influential descendants
Showing 1 of 1 · See all- K223254C2 XploreInomed Medizintechnik GmbH · 2023 · cites it directly0descendants
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 | K031510 | Nim-Spine | Medtronic Xomed | 2003 | — |
| −2 | K083124 | NIM 3.0 | Medtronic Xomed, Inc. | 2009 | 3 |
| −1 | K111647 | C2 Nervemonitor System with Accessories | Inomed Medizintechnik GmbH | 2011 | — |
| 0 (this device) | K152505 | C2 NerveMonitor System | Inomed Medizintechnik GmbH | 2016 | — |
| +1 | 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 |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K111647 | C2 Nervemonitor System with AccessoriesSummary page 4…Predicate Information 510(k) Number Product Code Trade Name Manufacturer K111647 ETN, GWF C2 NerveMonitor inomed Medizintechnik System… | 2011 |
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 |
|---|---|---|---|
| K223254 | C2 Xplore | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2019 | Class II | Z-0023-2020 | Device Design | Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury. |
| Jul 31, 2019 | Class II | Z-0024-2020 | Device Design | Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K223254 (Inomed Medizintechnik GmbH, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The C2 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 nerve roots. The C2 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…
Read the full statement (145 words)
The C2 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 nerve roots. The C2 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 C2 NerveMonitor System Monitoring Procedures include:
Extracranial, Intratemporal, Extratemporal, Neck Dissections, and Upper and Lower Extremities.
Indications for C2 NerveMonitor System monitoring of Spinal procedures include:
Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical 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/K152505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152505: C2 NerveMonitor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152505
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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