# K263010: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

- Pathway: 510(k) (Special)
- Applicant: inomed Medizintechnik GmbH
- Decided: Sep 24, 2026 after 27 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K941811 (1994). 211 ancestors in all.
No later device cites it as a predicate yet.
0 of 212 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233292: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress, Inomed Medizintechnik GmbH (2023) Summary page 6.
- K162199: Cascade IOMAX Intraoperative Monitor, Cadwell Industries, Inc. (2017) Summary page 6.

## Indications for use
Indications for Use: The product is used for intraoperative monitoring and testing during surgical procedures to examine neuronal tissue (central and peripheral nervous system) by recording and stimulation. The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations: •Measurement: -Auditory evoked potentials (AEP) -Electroencephalography (EEG) -Electrocorticography (ECoG) -E-ectromyography (EMG) -Somatosensory evoked potentials (SSEP) -Motor evoked potentials (MEP) -Visual evoked potentials (VEP) -Train of Four (TOF) • Stimulation: -Transcranial electrical stimulation (TES) -Direct cortical and subcortical stimulation (DCS) -Direct nerve stimulation (DNS) -Transcutaneous intraoperative nerve stimulation (TINS) -Direct muscle stimulation (DMS) -Stimulation for visual evoked potentials (VEP)

Source page: https://510kreport.com/device/K263010
Methodology: https://510kreport.com/methodology