# K971819: Epoch 2000 Neurological Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Axon Systems, Inc.
- Decided: Nov 20, 1997 after 188 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: 1 generation back to K842956 (1984). 4 ancestors in all.
464 later devices descend from it; 1 cites it directly.
1 of 469 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900482: Software & Hardware Addition to Sentinel-4 Eeg, Axon Systems, Inc. (1990) Summary page 3.
- K914571: Neurotrac II, Moberg Medical, Inc. (1992) Summary page 2.
- K842956: Nicolet Viking, Nicolet Biomedical Instruments (1984) Summary page 2.
- K950270: Nmi Software, Nicolet Biomedical, Inc. (1995) Summary page 2.

## Most influential descendants
- K022785: Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation (2002), 463 descendants of its own
- K032741: Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation (2003), 462 descendants of its own
- 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

## Indications for use
The Epoch 2000 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 the health care professionals with information to help access a patient’s neurological status during surgery or long-term monitoring in the ICU.

Source page: https://510kreport.com/device/K971819
Methodology: https://510kreport.com/methodology