# K062580: GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784)

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Dec 21, 2007 after 477 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: 6 generations back to K761301 (1977). 10 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023459: Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories, Datex-Ohmeda (2003) Summary page 1.
- K050835: Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories, GE Healthcare (2005) Summary page 1.

## Most influential descendants
- K220448: Disposable Non-invasive EEG Sensor (2023), 1 descendant of its own
- K082540: GE Entropy Sensor (2008), 1 descendant of its own
- K240668: Amydi-med Disposable Non-invasive EEG electrodes (2024), 0 descendants of its own
- K103129: Entropy Easyfit Sensor (2011), 0 descendants of its own

## Indications for use
This GE Entropy Sensor is intended to be used for adults 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 Use the sensor cable only with GE Entropy measurement devices together with GE Entropy Sensor or Entropy Sensor

Source page: https://510kreport.com/device/K062580
Methodology: https://510kreport.com/methodology