# K021376: Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A Software

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda
- Decided: Jul 24, 2002 after 84 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: 1 generation back to K000168 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000168: CS/3 Critical Care Monitor with S-ICU99(a), Datex-Ohmeda (2000) Summary page 4.

## Most influential descendants
- K071889: Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A Software (2008), 0 descendants of its own

## Indications for use
The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients. The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents. The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K021376
Methodology: https://510kreport.com/methodology