# K051400: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or F-CU5(P) Monitor Frame Options

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Jan 20, 2006 after 234 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: 3 generations back to K000815 (2000). 3 ancestors in all.
48 later devices descend from it; 3 cite it directly.
1 of 52 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030812: Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software, Datex-Ohmeda (2003) Summary page 2.

## Most influential descendants
- 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
- K131223: Carescape Monitor B650 (2013), 13 descendants of its own

## Indications for use
The Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE05 and L-ANE05A Software, using F-CU8 or F-CU5(P) Monitor Frame Options and E-EXT Extension Module and E-REC Recorder Module 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/5 T Anesthesia Monitor with L- L-ANE05and L-ANE05A 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- L-ANE05and L-ANE05A software is also indicated for documenting patient care related information. The S/5TM Anesthesia Monitor with L-ANE05and L-ANE05A software is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K051400
Methodology: https://510kreport.com/methodology