510(k) · Cleared
ClearedMEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soterix Medical, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Mar 25, 2024 as substantially equivalent to K190703 (Neurosoft, Ltd., 2021) after a 94-day review. Its family tree reaches back 2 generations to 2010.
- Decided
- Mar 25, 2024
- Review
- 94 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K093304 (2010). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K190703 | Neuro-IOM system with Neuro-IOM.NET softwareSummary page 5…ication and 21 CFR 882.1870, Class II Product Code: GWF - Evoked response electrical stimulator Device Class: Class II Predicate Device: K190703 Neuro-IOM system with Neuro-IOM.NET software models -32/B -32/S -16/S… | 2021 |
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 14 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
MEGA-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 three different configurations: I. 32/B II. 32/S III. 16/S The system ensures the…
Read the full statement (136 words)
MEGA-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 three different configurations:
I. 32/B
II. 32/S
III. 16/S
The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potential), MEP (motor evoked potential), EEG (electroencephalography), AEP (auditory evoked potential), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed.
The system is not intended to measure vital signs. It records the data to be interpreted by the neuromonitoring specialist.
MEGA-IOM system is intended for use in adults age 18 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234080 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234080: MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234080
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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