# K223254: C2 Xplore

- Pathway: 510(k) (Traditional)
- Applicant: Inomed Medizintechnik GmbH
- Decided: Jan 27, 2023 after 98 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K980148 (1998). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152505: C2 NerveMonitor System, Inomed Medizintechnik GmbH (2016) Summary page 4.

## Indications for use
The C2 Xplore is designed for use in the operating room to measure and display the neurophysiological signals. The system supports the application of Electromyography (EMG) for the purposes of intraoperative neuromonitoring of the peripheral nervous system. The system is not intended for monitoring life-sustaining functions.

Source page: https://510kreport.com/device/K223254
Methodology: https://510kreport.com/methodology