510(k) · Cleared
Recalled · Class I · 2025NIM Vital, Nerve Integrity Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Oct 28, 2020 as substantially equivalent to K083124 (Medtronic Xomed, Inc., 2009) after a 218-day review. Its family tree reaches back 5 generations to 1998. 1 of the 17 devices in its family, counting itself, has a Class I recall. It has been recalled 4 times, including a Class I recall.
- Decided
- Oct 28, 2020
- Review
- 218 days
- Class
- Class II
- Product code
- GWF
- Recalls
- 4 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 5 generations to K980148 (1998). 16 ancestors in all, the oldest K842956 (1984). No later device cites it as a predicate yet. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- 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 deviceK200759 NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc. · 2020
View 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) | K200759 | NIM Vital, Nerve Integrity Monitor | Medtronic Xomed, Inc. | 2020 | — |
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 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K083124 | NIM 3.0Summary page 4…Surgical nerve stimulator/locator (21 CFR 874.1820, Product Code ETN, Class II) Premarket Notification: K083124 Medtronic… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 10, 2025 | Class II | Z-1623-2025 | Software change control | Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention. |
| Jun 24, 2024 | Class I | Z-2409-2024 | Under Investigation by firm | Potential for false negative response on the NIM Vital Nerve Monitoring System |
| May 3, 2022 | Class II | Z-1224-2022 | Software Design Change | Software anomaly was identified. |
| May 3, 2022 | Class II | Z-1223-2022 | Software Design Change | Software anomaly was identified. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 16 ancestors have a recall of any class.
- 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. 2020, 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 NIM Vital™ System is intended for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor and mixed motor-sensory nerves and registering EMG responses during surgery.
The NIM Vital™ System may be used for EMG monitoring in support of surgical procedures including:
Intracranial, Extracranial, Intratemporal, Extratemporal and surgeries associated with the Neck, Spine, Thorax, and Upper and Lower Extremities.
The NIM Vital™ System is contraindicated for use with paralyzing anesthetic agents that will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200759: NIM Vital, Nerve Integrity Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200759
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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