510(k) · Cleared
Recalled · Class II · 2010NIM 3.0
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 Feb 27, 2009 as substantially equivalent to K031510 (Medtronic Xomed, 2003) and 1 other predicate after a 128-day review. Its family tree reaches back 4 generations to 1998. 1 of the 46 devices in its family, counting itself, has a Class I recall. 30 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 27, 2009
- Review
- 128 days
- Class
- Class II
- Product code
- GWF
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 4 generations to K980148 (1998). 15 ancestors in all, the oldest K842956 (1984). 30 later devices descend from it, 6 citing it directly. 1 of the 46 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK980148 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1998
- 3 generations backK992869 Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 1999
- 2 generations backK014165 Stimulus - Dissection InstrumentsMedtronic Xomed, Inc. · 2002
- 1 generation backK031510 Nim-SpineMedtronic Xomed · 2003
- This deviceK083124 NIM 3.0Medtronic Xomed, Inc. · 2009
- Descendant · cites it directly · 9 of its ownK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- Descendant · cites it directly · 7 of its ownK162313 NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017
- Descendant · cites it directly · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 5 of its ownK212166 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2022
- Descendant · 2 generations on · 4 of its ownK213849 SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200759 NIM Vital, Nerve Integrity Monitorcites it directly · 2020
Most influential descendants
Showing 5 of 30 · See all- K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019 · cites it directly9descendants
- K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017 · cites it directly7descendants
- K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · cites it directly7descendants
- K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH · 2022 · 2 generations on5descendants
- K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K980148 | Neurosign 800, 8 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1998 | — |
| −3 | K992869 | Xomed Ball-Tip Monopolar Stimulator Probe | Xomed, Inc. | 1999 | — |
| −2 | K014165 | Stimulus - Dissection Instruments | Medtronic Xomed, Inc. | 2002 | — |
| −1 | K031510 | Nim-Spine | Medtronic Xomed | 2003 | — |
| 0 (this device) | K083124 | NIM 3.0 | Medtronic Xomed, Inc. | 2009 | — |
| +1 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +1 | K162313 | NuVasive Next Generation NVM5 System | Nu Vasive, Incorporated | 2017 | — |
| +1 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 3 |
| +2 | K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022 | — |
| +2 | K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 1 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K031510 | Nim-SpineSummary page 1…) Marketed device claiming equivalence to The Medtronic Nerve Integrity Monitor 3.0 and accessories are substantially equivalent to the Medtronic NIM Spine (K031510) and the NIM PRS (K024316). Device Description NIM 3.0 is a multi-channel intraoperative neurophysiological monitor capabl… | 2003 |
| * | K024316 | Nim-PRSSummary page 1…g equivalence to The Medtronic Nerve Integrity Monitor 3.0 and accessories are substantially equivalent to the Medtronic NIM Spine (K031510) and the NIM PRS (K024316). Device Description NIM 3.0 is a multi-channel intraoperative neurophysiological monitor capable of connecting vari… | 2003 |
What descends from it? (30)
See all 306 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182542 | The EPAD 2 System | 2019 | 9 |
| K162313 | NuVasive Next Generation NVM5 System | 2017 | 7 |
| K162199 | Cascade IOMAX Intraoperative Monitor | 2017 | 7 |
| K111647 | C2 Nervemonitor System with Accessories | 2011 | 2 |
| K181559 | Neurosign V4 Intraoperative Nerve Monitor | 2018 | 1 |
| K200759 | NIM Vital, Nerve Integrity Monitor Class I | 2020 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2010 | Class II | Z-2342-2012 | Device Design | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode… |
| Sep 27, 2010 | Class II | Z-2344-2012 | Device Design | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode… |
| Sep 27, 2010 | Class II | Z-2343-2012 | Device Design | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K182542 (Safeop Surgical, Inc., 2019) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K031510.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 3.0 is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. The APS electrode is an accessory intended for providing afitomatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems. Indications for NIM 3.0 EMG Monitoring Procedures include: Intracranial, Extracranial, Intratemporal, Extratemporal, Neck…
Read the full statement (103 words)
The NIM 3.0 is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. The APS electrode is an accessory intended for providing afitomatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.
Indications for NIM 3.0 EMG Monitoring Procedures include:
Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections,
Thoracic Surgeries, and Upper and Lower Extremities
Indications for Spinal procedures which may use NIM 3.0 EMG monitoring
include:
Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy,
Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical
Procedures, and Thoracic Surgical Procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083124: NIM 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083124
Report an extraction error
Are you the manufacturer?
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