# K230073: Okti

- Pathway: 510(k) (Traditional)
- Applicant: Compumedics Limited
- Decided: Feb 9, 2023 after 30 days
- Product code: GWQ (Full-Montage Standard 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: 4 generations back to K000068 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093223: Compumedics Grael System, Models: Grael, Grael Ecg, Compumedics Limited (2010) Summary page 4.

## Indications for use
The Okti System is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various neurological disorders. The Okti is designed for use in a hospital or other clinical environment. The Okti is only to be used under the direction of a physician.

Source page: https://510kreport.com/device/K230073
Methodology: https://510kreport.com/methodology