# K233292: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

- Pathway: 510(k) (Special)
- Applicant: Inomed Medizintechnik GmbH
- Decided: Oct 27, 2023 after 28 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: 18 generations back to K941811 (1994). 210 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 212 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress, Inomed Medizintechnik GmbH (2022) Summary page 5.

## Most influential descendants
- K263010: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2026), 0 descendants of its own

## 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: o Auditory evoked potentials (AEP) o Electroencephalography (EEG) o Electrocorticography (ECoG) o Electromyography (EMG) o Somatosensory evoked potentials (SSEP) o Motor evoked potentials (MEP) o Train of Four (TOF) • Stimulation: o Transcranial electrical stimulation (TES) o Direct cortical and subcortical stimulation (DCS) o Direct nerve stimulation (DNS) o Transcutaneous intraoperative nerve stimulation (TINS) o Direct muscle stimulation (DMS)

Source page: https://510kreport.com/device/K233292
Methodology: https://510kreport.com/methodology