# K050835: Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: May 6, 2005 after 35 days
- Product code: OLW (Index-Generating Electroencephalograph Software)
- 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: 5 generations back to K761301 (1977). 9 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 17 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.

## Most influential descendants
- K062580: GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784) (2007), 4 descendants of its own
- K061907: Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories (2008), 2 descendants of its own
- 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

## Indications for use
The Datex-Ohmeda Entropy Module, E-ENTROPY and accessories are indicated for monitoring the state of the central nervous system (CNS) by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals in the anesthesia environment. The spectral entropies, Response Entropy (RE) and State Entropy (SE), are processed EEG and FEMG variables, and may be used as an aid in monitoring the effects of certain anesthetic agents. The Entropy module is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K050835
Methodology: https://510kreport.com/methodology