510(k) · Cleared
Recalled · Class II · 2015Protektor 32
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Aug 11, 2010 after a 294-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 20 later devices descend from it. It has been recalled once.
- Decided
- Aug 11, 2010
- Review
- 294 days
- Class
- Class II
- Product code
- GWF
- Recalls
- 1
- Predicates
- 0
20 later devices descend from it, 3 citing it directly.
- This deviceK093304 Protektor 32Natus Medical, Inc. · 2010
- Descendant · cites it directly · 11 of its ownK132616 EPADSafeop Surgical, Inc. · 2014
- Descendant · 2 generations on · 9 of its ownK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- 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 · 3 generations on · 4 of its ownK213849 SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K132616EPADSafeop Surgical, Inc. · 2014 · cites it directly11descendants
- K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019 · 2 generations on9descendants
- 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 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093304 | Protektor 32 | Natus Medical, Inc. | 2010 | — |
| +1 | K132616 | EPAD | Safeop Surgical, Inc. | 2014 | — |
| +2 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +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 | — |
| +3 | K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (20)
See all 203 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 2, 2015 | Class II | Z-1067-2015 | Software design | Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K132616 (Safeop Surgical, Inc., 2014) has gone furthest, with 11 descendants of its own.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Protektor32 channel system, composed of both hardware and software, is intended to be used for intraoperative neurological monitoring. The instrument uses Electroencephalography (EEG), Evoked Potentials (EP), Electromyography (EMG) and Transcranial Motor Evoked Potential (TcMEP ) stimulation techniques to provide the healthcare professionals with information to help assess a patient's neurological status during surgery. The TcMEP mode is intended for…
Read the full statement (214 words)
The Protektor32 channel system, composed of both hardware and software, is intended to be used for intraoperative neurological monitoring. The instrument uses Electroencephalography (EEG), Evoked Potentials (EP), Electromyography (EMG) and Transcranial Motor Evoked Potential (TcMEP ) stimulation techniques to provide the healthcare professionals with information to help assess a patient's neurological status during surgery.
The TcMEP mode is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
The EPWorks software, an integral part of the system, is intended to allow a medical professional to manually configure stimulation and acquisition parameters and to manually create EEG, EP, EMG and TcMEP protocols according to their own requirements. The intended use for each of the software's outputs is as follows:
* The EEG, EP, and EMG waveforms are intended to help the user assess a patient's neurological status during surgery.
* Simple waveform parameters (e.g., amplitude. latency), and user-defined Fast Fourier transform (FFT) displays (compressed spectral array or CSA, density spectral array or OSA) are intended to help the user analyze the EEG and EP waveforms.
This device is intended to be used by qualified medical practitioners, trained in EEG, EP and EMG who will exercise professional judgment when using the information.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K093304 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093304: Protektor 32.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093304
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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