510(k) · Cleared
ClearedNeuro-IOM system with Neuro-IOM.NET software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurosoft, Ltd. · GWF Stimulator, Electrical, Evoked Response
Cleared on May 22, 2021 as substantially equivalent to K093304 (Natus Medical, Inc., 2010) after a 796-day review. Its family tree reaches back 1 generation to 2010. 1 later device descends from it.
- Decided
- May 22, 2021
- Review
- 796 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093304 (2010). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK093304 Protektor 32Natus Medical, Inc. · 2010 · Recalled
- This deviceK190703 Neuro-IOM system with Neuro-IOM.NET softwareNeurosoft, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK234080 MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)Soterix Medical, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)Soterix Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093304 | Protektor 32 | Natus Medical, Inc. | 2010 | 1 |
| 0 (this device) | K190703 | Neuro-IOM system with Neuro-IOM.NET software | Neurosoft, Ltd. | 2021 | — |
| +1 | K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | Soterix Medical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K093304 | Protektor 32Summary page 4…rology PREDICATE DEVICES: Neurosoft identified the following legally marketed devices as substantially equivalent: - Xltek Protektor 32, NATUS MEDICAL, INC., K093304 DEVICE DESCRIPTION: Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neur… | 2010 |
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 |
|---|---|---|---|
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | 2024 | 0 |
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?
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient’s neurophysiological status. The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations: 1.32/B II. 32/8 III. 16/S The system ensures the following…
Read the full statement (123 words)
Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient’s neurophysiological status.
The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways.
It is provided in III different configurations:
1.32/B
II. 32/8
III. 16/S
The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (auditory evoked potentials), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed.
The system is not intended to measure the vital signs. It records the data to be interpreted by the neuromonitoring specialist.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190703: Neuro-IOM system with Neuro-IOM.NET software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190703
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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