# K093223: Compumedics Grael System, Models: Grael, Grael Ecg

- Pathway: 510(k) (Traditional)
- Applicant: Compumedics Limited
- Decided: Jan 15, 2010 after 94 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: 3 generations back to K000068 (2000). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003175: Compumedics Siesta System, Compumedics Limited (2000) Summary page 1.
- K040194: Compumedics Summit IP, Compumedics USA, Ltd. (2004) Summary page 1.
- K072201: Compumedics Somte PSG Recording System, Compumedics Limited (2008) Summary page 1.
- K000068: Compumedics E-Series Eeg System, Compumedics Neuro Science Pty, Ltd. (2000) Summary page 1.
- K955841: Sleep System for Clinics & Research, Compumedics Ptd, Ltd. (1997) Summary page 1.
- K001564: Scan LT40 (40 Channels), Neuro Scan Labs (2000) Summary page 3.
- K081151: Compumedics Neuvo, Compumedics USA, Ltd. (2008) Summary page 1.

## Most influential descendants
- K230073: Okti (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K093223
Methodology: https://510kreport.com/methodology