# K082540: GE Entropy Sensor

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Nov 28, 2008 after 87 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K761301 (1977). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062580: GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784), GE Healthcare (2007) Summary page 1.

## Most influential descendants
- K103129: Entropy Easyfit Sensor (2011), 0 descendants of its own

## Indications for use
This GE Entropy Sensor is intended to be used for adults and pediatric patients older than 2 years with GE Entropy measurement devices to enable recording of physiological signals (such as EEG). To connect this sensor to the measurement device, use the GE Entropy Cable.

Source page: https://510kreport.com/device/K082540
Methodology: https://510kreport.com/methodology