# 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

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare Finland Oy
- Decided: Sep 23, 2009 after 22 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: 4 generations back to K000815 (2000). 4 ancestors in all.
33 later devices descend from it; 1 cites it directly.
1 of 38 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051400: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or F-CU5(P) Monitor Frame Options, GE Healthcare (2006) Summary page 1.

## Most influential descendants
- 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
- K190008: Carescape One (2019), 11 descendants of its own
- K200494: CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES (2020), 10 descendants of its own

## Indications for use
The Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 or L-ANE07A software is intended for multiparameter patient monitoring with optional patient care documentation. The S/S Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory; gastrointestinal/regional perfusion, Entropy (State Entropy and Response Entropy) and neurophysiological status of all hospital patients. When the BIS module is used with the S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A, it is intended for use by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The Bispectral index (BIS), a processed EEG variable, and one component of the BIS module, may be used in adults as an aid in monitoring the effects of certain anesthetic agents. The Bispectral index is a complex technology, intended for use only as an adjunct to clinical judgment and training. In addition, the clinical utility, risk/benefit, and application of BIS have not undergone full evaluation in the pediatric population. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is also indicated for documenting patient care related information. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K092680
Methodology: https://510kreport.com/methodology