# K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

- Pathway: 510(k) (Traditional)
- Applicant: Inomed Medizintechnik GmbH
- Decided: Jan 7, 2022 after 179 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: 17 generations back to K941811 (1994). 209 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 215 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162199: Cascade IOMAX Intraoperative Monitor, Cadwell Industries, Inc. (2017) Summary page 4.

## Most influential descendants
- K233292: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2023), 1 descendant of its own
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own
- K263010: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2026), 0 descendants of its own
- K230415: Cadwell Guardian (2023), 0 descendants of its own
- K223765: ATEC Lateral Navigation Instruments (2023), 0 descendants of its own

## Indications for use
ISIS Headbox 5042xx products: The products are intended for intraoperative neuromonitoring; for recording of electrophysiological signals and stimulating of nerve and muscle tissues. The products are intended for use in the operating room to measure and display the electrical signals generated by muscle, peripheral nerves and the central nervous system. The products support the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), and Auditory Evoked Potentials (AEP). The products are not intended for monitoring life-sustaining functions. ISIS Neurostimulator 504180: The ISIS Neurostimulator is intended for provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. It is suitable for continuous operation and can be used in the following fields: – Transcranial electrical stimulation (TES) – Direct cortical stimulation (DCS) – Direct nerve stimulation (DNS) – Transcutaneous electrical nerve stimulation (TNS) – Direct muscle stimulation (DMS)

Source page: https://510kreport.com/device/K212166
Methodology: https://510kreport.com/methodology