# K000068: Compumedics E-Series Eeg System

- Pathway: 510(k) (Traditional)
- Applicant: Compumedics Neuro Science Pty, Ltd.
- Decided: Mar 13, 2000 after 63 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
569 later devices descend from it; 4 cite it directly.
1 of 570 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021807: Grass-Telefactor AS40 Amplifier System (2002), 471 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
- K111520: Ipc Powerease System (2011), 418 descendants of its own

## Recalls of this device
- Feb 24, 2005 · Not classified · Z-0652-05: Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin.

Source page: https://510kreport.com/device/K000068
Methodology: https://510kreport.com/methodology