# K093304: Protektor 32

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical, Inc.
- Decided: Aug 11, 2010 after 294 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K132616: EPAD (2014), 11 descendants of its own
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own
- K213849: SafeOp 2: Neural Informatix System (2022), 4 descendants of its own

## Recalls of this device
- Jan 2, 2015 · Class II · Z-1067-2015: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K093304
Methodology: https://510kreport.com/methodology