# K013389: Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda
- Decided: Jan 10, 2002 after 90 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: 3 generations back to K761301 (1977). 7 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011534: Eeg Mis Monitor Model # a-2000; Bis Engine, Aspect Medical Systems, Inc. (2001) Summary page 1.
- K994330: Aspect Medical Systems Eeg Sensor, Model 186-0076, Aspect Medical Systems, Inc. (2000) Summary page 1.
- K002734: Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106, Aspect Medical Systems, Inc. (2000) Summary page 1.
- K001980: Aspect Medical Systems Pediatric Bis Eeg Sensor, Model 186-0110, Aspect Medical Systems, Inc. (2000) Summary page 1.

## Most influential descendants
- K023459: Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories (2003), 8 descendants of its own
- K050835: Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories (2005), 7 descendants of its own
- 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

## Indications for use
The Datex-Ohmeda BIS module, M-BIS and accessories are indicated for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) signals of all hospitalized patients. The Bispectral index (BIS), a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K013389
Methodology: https://510kreport.com/methodology