# K071889: Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A Software

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: May 19, 2008 after 315 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000168 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021376: Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A Software, Datex-Ohmeda (2002) Summary page 2.

## Indications for use
The S/5 Critical Care Monitor with L-ICU05 and L-ICU05A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, and neurophysiological status of all patients. When the BIS module is used with the S/5 Critical Care Monitor with L-ICU05 and L-ICU05A, it is intended for use by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The Bispectral index (BIS), a processed EEG variable, and one component of the BIS measurement, may be used in adults as an aid in monitoring the effects of certain anesthetic agents. The Bispectral index is a complex technology, intended for use only as an adjunct to clinical judgement and training. In addition, the clinical utility, risk/benefit, and application of BIS have not undergone full evaluation in the pediatric population. The S/5 Critical Care Monitor with L-ICU05 and L-ICU05A software is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K071889
Methodology: https://510kreport.com/methodology