# K053599: Spacelabs Medical Multigas Analyzer Module 91518 and Accessories

- Pathway: 510(k) (Special)
- Applicant: Spacelabs Medical, Inc.
- Decided: Apr 19, 2006 after 117 days
- Product code: CBR (Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.))
- Device class: 2
- Regulation: 21 CFR 868.1700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001814 (2000). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954962: Spacelabs Medical Multigas Analyzer, Spacelabs, Inc. (1996) Summary page 2.
- K051092: Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov, E-Caio, E-Covx, E-Cov, E-CO & Accesacc, GE Healthcare (2005) Summary page 2.

## Most influential descendants
- K112173: Speacelabs Multigas Module (2011), 2 descendants of its own
- K121017: Capnography Pad (92516) (2012), 1 descendant of its own
- K130112: Capno Module, 92517 (2013), 0 descendants of its own

## Recalls of this device
- Jun 8, 2011 · Not classified · Z-2902-2011: Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to only the trend table d
- Oct 8, 2007 · Not classified · Z-0660-2008: Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa.

## Indications for use
The Spacelabs Medical Multigas Analyzer Module 91518 (Module 91518) is intended to provide a means of monitoring a variety of gas concentrations and to alert clinical personnel when the concentration of anesthetic agent, oxygen, carbon dioxide or nitrous oxide falls outside of user defined limits. The Module 91518 is capable of automatically identifying which anesthetic agent(s) is being administered. The Module 91518 is intended to be used with, and is controlled by, any Spacelabs Medical monitor, except the SLP100. The Module 91518 is intended for use monitoring all hospitalized patients under the direction of qualified medical personnel. Although the Module 91518 alarms when the duration between breaths exceeds user defined limits, it is not intended to be a primary diagnostic apnea monitor and/or recording device.

Source page: https://510kreport.com/device/K053599
Methodology: https://510kreport.com/methodology