# K050143: Omnipro System

- Pathway: 510(k) (Traditional)
- Applicant: Mays and Associates, Inc.
- Decided: Feb 1, 2005 after 11 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- 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 K946094 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000068: Compumedics E-Series Eeg System, Compumedics Neuro Science Pty, Ltd. (2000) Summary page 1.
- K946094: Cadwell Easy Ambulatory Eeg, Cadwell Laboratories, Inc. (1995) Summary page 1.

## Indications for use
The OmniProTM System is intended for the measuring, recording and analysis of the electrical activity of a patient's brain through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical setting for EEG/EMG/EOG/ECG/Air Flow/Oximetry.

Source page: https://510kreport.com/device/K050143
Methodology: https://510kreport.com/methodology