# K061907: Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Mar 27, 2008 after 631 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: 6 generations back to K761301 (1977). 10 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K050835: Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories, GE Healthcare (2005) Summary page 2.

## Most influential descendants
- K150298: Entropy Module, E-ENTROPY-01 (2015), 0 descendants of its own
- K103129: Entropy Easyfit Sensor (2011), 0 descendants of its own

## Indications for use
The Datex-Ohmeda Entropy Module, E-Entropy and accessories are indicated for adult and pediatric patients older than 2 years within a hospital for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals. The spectral entropies, Response Entropy (RE) and State Entropy (SE), are processed EEG and FEMG variables. The Entropy measurement is to be used as an adjunct to other physiological parameters. In adult patients, Response Entropy (RE) and State Entropy (SE) may be used as an aid in monitoring the effects of certain anesthetic agents, which may help the user titrate anesthetic drugs according to the individual needs of adult patients. Furthermore in adults, the use of Entropy parameters may be associated with a reduction of anesthetic use and faster emergence from anesthesia. The Entropy module is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K061907
Methodology: https://510kreport.com/methodology