# K021279: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A Software

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda
- Decided: Jul 19, 2002 after 88 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: 1 generation back to K000815 (2000). 1 ancestor in all.
55 later devices descend from it; 1 cites 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)
- K000815: AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a), Datex-Ohmeda (2000)

## Most influential descendants
- K030812: Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software (2003), 54 descendants of its own
- 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

## Indications for use
The S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients. The S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A 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/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software is also indicated for documenting patient care related information. The S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K021279
Methodology: https://510kreport.com/methodology