# K131882: Geodesiceeg System 400 Series (Ges 400)

- Pathway: 510(k) (Traditional)
- Applicant: Electrical Geodesics, Inc.
- Decided: Feb 12, 2014 after 232 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933233 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063797: Geodesic Eeg System 300, Electrical Geodesics, Incorporated (2007) Summary page 1.

## Recalls of this device
- Jun 14, 2021 · Class I · Z-1974-2021: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain c

## Indications for use
The Geodesic EEG System 400 Series (GES 400) is intended to measure and record the electrical activity of the patient's brain, It can be used on adults, children, and infants.

Source page: https://510kreport.com/device/K131882
Methodology: https://510kreport.com/methodology