# K022485: Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 and L-CANE02A Software

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda
- Decided: Oct 3, 2002 after 66 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 K002478 (2000). 1 ancestor in all.
85 later devices descend from it; 1 cites it directly.
1 of 87 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002478: S/5 Compact Anesthesia Monitor with S-00A05, S-00A06. L-00A07, L00A08, Datex-Ohmeda, Inc. (2000) Summary page 2.

## Most influential descendants
- K041790: Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and LCANE03A Software (2004), 84 descendants of its own
- K053193: PM-8000 Express Patient Monitor, Model PM-8000 Express (2006), 48 descendants of its own
- K070791: PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express (2007), 47 descendants of its own
- K061185: Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and L-CANE05A Software (2006), 34 descendants of its own
- K102239: Carescape Monitor B650 (2010), 32 descendants of its own

## Indications for use
The S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A 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™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A 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™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is also indicated for documenting patient care related information. The S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K022485
Methodology: https://510kreport.com/methodology