510(k) · Cleared
Recalled · 2011Spacelabs Medical Multigas Analyzer Module 91518 and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Medical, Inc. · CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Cleared on Apr 19, 2006 as substantially equivalent to K954962 (Spacelabs, Inc., 1996) and 1 other predicate after a 117-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 19, 2006
- Review
- 117 days
- Class
- Class II
- Product code
- CBR
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001814 (2000). 3 ancestors in all, the oldest K954962 (1996). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001814 Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01)…Datex-Ohmeda · 2000
- 1 generation backK051092 Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx)…GE Healthcare · 2005 · Recalled
- This deviceK053599 Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesSpacelabs Medical, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK112173 Speacelabs Multigas ModuleSpacelabs Healthcare · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK121017 Capnography Pad (92516)Spacelabs Healthcare · 2012
- Descendant · 3 generations on · 0 of its ownK130112 Capno Module, 92517Spacelabs Healthcare · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and… | Datex-Ohmeda | 2000 | — |
| −1 | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx… | GE Healthcare | 2005 | 2 |
| 0 (this device) | K053599 | Spacelabs Medical Multigas Analyzer Module 91518 and Accessories | Spacelabs Medical, Inc. | 2006 | — |
| +1 | K112173 | Speacelabs Multigas Module | Spacelabs Healthcare | 2011 | 1 |
| +2 | K121017 | Capnography Pad (92516) | Spacelabs Healthcare | 2012 | — |
| +3 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K954962 | Spacelabs Medical Multigas AnalyzerSummary page 2…le 91518 is substaatially equivalent in design concepts, technologies Discussion: and materials to the combination of the Spacelabs Medical Module 90518 (K954962) and the Datc-Ohmeda Compact Airway Module E-CAiOVX (K051092). The Module 915;18 was validated through rigorous tes… | 1996 |
| * | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov…Summary page 2…ssion: and materials to the combination of the Spacelabs Medical Module 90518 (K954962) and the Datc-Ohmeda Compact Airway Module E-CAiOVX (K051092). The Module 915;18 was validated through rigorous testing that, in part, support the compliance of the Module 9151… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112173 | Speacelabs Multigas Module | 2011 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 8, 2011 | Not classified | Z-2902-2011 | Software design | 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 data. |
| Oct 8, 2007 | Not classified | Z-0660-2008 | Software design | Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K112173 (Spacelabs Healthcare, 2011) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K954962.
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.
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 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…
Read the full statement (125 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053599: Spacelabs Medical Multigas Analyzer Module 91518 and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053599
Report an extraction error
Are you the manufacturer?
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