# K022740: Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A Software

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda
- Decided: Nov 14, 2002 after 87 days
- Product code: MLD (Monitor, St Segment With Alarm)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002158 (2000). 1 ancestor in all.
13 later devices descend from it; 2 cite it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002158: S/5 Compact Critical Care Monitor with S-00C03 or S-00C04 Software, Datex-Ohmeda, Inc. (2000) Summary page 4.

## Most influential descendants
- K043276: Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec Module (2004), 11 descendants of its own
- K120598: Procare Monitor B40 (2012), 10 descendants of its own
- K130584: Monitor B40 (2013), 8 descendants of its own
- K133576: Monitor B40 (2014), 7 descendants of its own
- K151063: Monitor B40 (2015), 5 descendants of its own

## Recalls of this device
- Feb 6, 2006 · Not classified · Z-1995-2009: GE Healthcare (Datex-Ohmeda) S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software had an issue where the Heart Rate (HR) was displaying
- Feb 6, 2006 · Not classified · Z-1994-2009: GE Healthcare (Datex-Ohmeda) S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software had an issue where the Heart Rate (HR) was displaying

## Indications for use
The S / 5 T M Compact Critical Care Monitor with L-CICUO2 and L-CICU02A 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 T M Compact Critical Care Monitor with L-CICUO2 and L-CICU02A 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 T M Compact Critical Care Monitor with L-CICUO2 and L-CICU02A software is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K022740
Methodology: https://510kreport.com/methodology