510(k) · Cleared
Recalled · Class II · 2014Speacelabs Multigas Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Healthcare · CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Cleared on Oct 5, 2011 as substantially equivalent to K053599 (Spacelabs Medical, Inc., 2006) after a 69-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 5, 2011
- Review
- 69 days
- Class
- Class II
- Product code
- CBR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001814 (2000). 4 ancestors in all, the oldest K954962 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK001814 Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01)…Datex-Ohmeda · 2000
- 2 generations backK051092 Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx)…GE Healthcare · 2005 · Recalled
- 1 generation backK053599 Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesSpacelabs Medical, Inc. · 2006 · Recalled
- This deviceK112173 Speacelabs Multigas ModuleSpacelabs Healthcare · 2011
- Descendant · cites it directly · 1 of its ownK121017 Capnography Pad (92516)Spacelabs Healthcare · 2012
- Descendant · 2 generations on · 0 of its ownK130112 Capno Module, 92517Spacelabs Healthcare · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and… | Datex-Ohmeda | 2000 | — |
| −2 | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx… | GE Healthcare | 2005 | 2 |
| −1 | K053599 | Spacelabs Medical Multigas Analyzer Module 91518 and Accessories | Spacelabs Medical, Inc. | 2006 | 2 |
| 0 (this device) | K112173 | Speacelabs Multigas Module | Spacelabs Healthcare | 2011 | — |
| +1 | K121017 | Capnography Pad (92516) | Spacelabs Healthcare | 2012 | — |
| +2 | K130112 | Capno Module, 92517 | Spacelabs Healthcare | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CBR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053599 | Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesSummary page 2…icate 510(k) Predicate Equivalent Devices: Number Manufacturer/ Model Spacelabs Multigas K053 599 Spacelabs Medical, Module, Model 92518 Inc. / Multigas… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121017 | Capnography Pad (92516) | 2012 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 18, 2014 | Class II | Z-2077-2014 | Process control | With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K121017 (Spacelabs Healthcare, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CBR devicesCBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · CBR
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · CBR
Too few CBR 510(k)s in any year since 2007 to give a median.
Recalls per year · CBR
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CBR
1in 2025
MAUDE reports naming product code CBR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (124 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112173: Speacelabs Multigas Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112173
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026