# K002158: S/5 Compact Critical Care Monitor with S-00C03 or S-00C04 Software

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Sep 6, 2000 after 51 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
No predicates in its family tree.
14 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022740: Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A Software (2002), 13 descendants of its own
- 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

Source page: https://510kreport.com/device/K002158
Methodology: https://510kreport.com/methodology