# K071020: Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU05 and L-CICU05A Software

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Jun 18, 2007 after 69 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- 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 K002158 (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)
- K022740: Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A Software, Datex-Ohmeda (2002) Summary page 2.

## Indications for use
The S/5TM Compact Critical Care Monitor with L-CICU05 and L-CICU05A 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/5TM Compact Critical Care Monitor with L-CICU05 and L-CICU05A 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/5TM Compact Critical Care Monitor with L-CICU05 and L-CICU05A software is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K071020
Methodology: https://510kreport.com/methodology