510(k) · Cleared
ClearedNeurosign V4 Intraoperative Nerve Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Magstim Company, Ltd. · PDQ Neurosurgical Nerve Locator
Cleared on Mar 17, 2021 as substantially equivalent to K181559 (Magstim Company, Ltd., 2018) and 1 other predicate after a 90-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Mar 17, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- PDQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K980148 (1998). 18 ancestors in all, the oldest K842956 (1984). No later device cites it as a predicate yet.
- 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 backK181559 Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd. · 2018 · Recalled
- This deviceK203684 Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd. · 2021
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 | K181559 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | 2018 | 1 |
| 0 (this device) | K203684 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | 2021 | — |
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 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K181559 | Neurosign V4 Intraoperative Nerve MonitorSummary page 5…Name Neurosurgical Nerve Locator Classification Neurosurgical Nerve Locator 21 CFR 874.1820, Class II, product code PDQ Predicate Devices K181559 Neurosign® V4 Intraoperative Nerve Monitor, The Magstim Company Limited (Primary Predicate Device), 21 CFR 874.1820, PDQ,… | 2018 |
| * | K053141 | Neurosign Motor Nerve Monitor, Models Neurosign 400 & 800Summary page 5…icate Devices K181559 Neurosign® V4 Intraoperative Nerve Monitor, The Magstim Company Limited (Primary Predicate Device), 21 CFR 874.1820, PDQ, ETN K053141 Neurosign® Nerve Monitor, Model Neurosign® 400 and Neurosign® 800, The Magstim Company Limited (Secondary Predicate), 21 C… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 18 ancestors have a recall of any class.
How does its category compare?
All PDQ devicesPDQ Neurosurgical Nerve Locator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The Neurosign® V4 Intraoperative Nerve Monitor is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal nerve roots.
Indications for Neurosign® V4 EMG Monitoring Procedures include: Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities.
Indications for spinal procedures which may use Neurosign® V4 EMG monitoring include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery and Open and Percutaneous Lumbar Procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203684: Neurosign V4 Intraoperative Nerve Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203684
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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