# K112173: Speacelabs Multigas Module

- Pathway: 510(k) (Special)
- Applicant: Spacelabs Healthcare
- Decided: Oct 5, 2011 after 69 days
- Product code: CBR (Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.))
- Device class: 2
- Regulation: 21 CFR 868.1700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001814 (2000). 4 ancestors in all.
2 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)
- K053599: Spacelabs Medical Multigas Analyzer Module 91518 and Accessories, Spacelabs Medical, Inc. (2006) Summary page 2.

## Most influential descendants
- 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 18, 2014 · Class II · Z-2077-2014: With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.

## Indications for use
The Spacelabs Multigas Module, Model 92518 (Model 92518) is intended to provide a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits. The multigas module is capable of automatically identifying which anesthetic agent(s) is being administered. The 92518 Multigas Module is intended to be used with and controlled by a Spacelabs Healthcare Ultraview-family monitor. The 92518 Multigas Module is intended to be used for monitoring all hospitalized patients, under the direction of qualified medical personnel. Although the 92518 Multigas Module 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/K112173
Methodology: https://510kreport.com/methodology