# K043276: Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec Module

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda
- Decided: Dec 23, 2004 after 27 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002158 (2000). 6 ancestors in all.
11 later devices descend from it; 1 cites it directly.
2 of 18 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.
- K023454: Datex-Ohmeda S/5 Single-Width Airway Module M-Minic and Accessories, Datex-Ohmeda (2003) Summary page 2.
- K933285: Datex as/3 TM Anaesthesia Monitor, Datex Division Instrumentarium Corp. (1994) Summary page 2.
- K933156: Datex as/3 Patient Monitor, Datex Division Instrumentarium Corp. (1994) Summary page 2.

## Most influential descendants
- 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
- K171580: Monitor B125, Monitor B105 (2017), 4 descendants of its own

## Recalls of this device
- Jun 11, 2014 · Class I · Z-2068-2014: Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values. Incorrect Et CO2/Fi CO2 value may impair clinical dec

## Indications for use
The S/5 FM with L-FICU04 or L-FICU04A software is indicated for monitoring of hemodynamics (including arrhythmia and ST-segment analysis) and respiratory status of all hospital patients. Extension module N-FCREC (option N-FCREC or N-FC) is indicated for monitoring C02 and respiration rate of all hospital patients. C02 measurements are indicated for patients weighing over 5kg (11 lbs). The S/5 FM Monitor and N-F(C)(REC) Extension Module are indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K043276
Methodology: https://510kreport.com/methodology