# K030812: Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda
- Decided: May 21, 2003 after 68 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 K000815 (2000). 2 ancestors in all.
54 later devices descend from it; 2 cite it directly.
1 of 57 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021279: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A Software, Datex-Ohmeda (2002) Summary page 3.

## Most influential descendants
- K051400: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or F-CU5(P) Monitor Frame Options (2006), 48 descendants of its own
- K092027: Carescape Monitor B850 (2009), 38 descendants of its own
- K092680: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO7 and L-ANEO7A Software Using F-CU8 or F-CU5 (P) Monitor Frame Options an (2009), 33 descendants of its own
- K102239: Carescape Monitor B650 (2010), 32 descendants of its own
- K132533: Carescape Monitor B450 (2013), 14 descendants of its own

## Indications for use
The S/5TM Anesthesia Monitor with L-ANE03 and L-ANE03A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response Entropy) and neurophysiological status of all hospital patients. The S/5TM Anesthesia Monitor with L-ANE03 and L-ANE03A 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 Anesthesia Monitor with L-ANE03 and L-ANE03A software is also indicated for documenting patient care related information. The S/5TM Anesthesia Monitor with L-ANE03 and L-ANE03A software is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K030812
Methodology: https://510kreport.com/methodology