# K061185: Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and L-CANE05A Software

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: May 15, 2006 after 17 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 K002478 (2000). 3 ancestors in all.
34 later devices descend from it; 2 cite 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)
- K041790: Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and LCANE03A Software, Datex-Ohmeda (2004) 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 S/5 Tm Compact Anesthesia Monitor with L-CANE05 and L-CANE05A 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/5 Tm Compact Anesthesia Monitor with L-CANE05 and L-CANE05A 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 Tm Compact Anesthesia Monitor with L-CANE05 and L-CANE05A software is also indicated for documenting patient care related information. The S/5 Tm Compact Anesthesia Monitor with L-CANE05 and L-CANE05A software is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K061185
Methodology: https://510kreport.com/methodology