# K032741: Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Axon Systems, Inc.
- Decided: Dec 16, 2003 after 103 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: 3 generations back to K842956 (1984). 7 ancestors in all.
462 later devices descend from it; 2 cite it directly.
1 of 470 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022785: Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation, Axon Systems, Inc. (2002) Summary page 1.
- K020400: Digitimer D185 Multipulse Cortical Stimulator, Meps, LLC (2002) Summary page 1.

## Most influential descendants
- K050798: Eclipse Neurological Workstation (2005), 460 descendants of its own
- K061113: Orthomon (2006), 450 descendants of its own
- K061639: Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and Vascular Doppler; Cardiomon (2006), 426 descendants of its own
- K111520: Ipc Powerease System (2011), 418 descendants of its own
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps (2013), 404 descendants of its own

## Indications for use
The EpochXP Neurological Monitor is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument uses EEG, evoked potentials and EMG techniques to provide health care professionals with information to help assess a patient's neurological status and guide treatment during surgery or long term monitoring in the ICU

Source page: https://510kreport.com/device/K032741
Methodology: https://510kreport.com/methodology