510(k) · Cleared
ClearedCapno Module, 92517
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Healthcare · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Mar 21, 2013 as substantially equivalent to K121017 (Spacelabs Healthcare, 2012) after a 64-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Mar 21, 2013
- Review
- 64 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001814 (2000). 6 ancestors in all, the oldest K954962 (1996). No later device cites it as a predicate yet.
- Root · 5 generations backK001814 Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01)…Datex-Ohmeda · 2000
- 4 generations backK051092 Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx)…GE Healthcare · 2005 · Recalled
- 3 generations backK053599 Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesSpacelabs Medical, Inc. · 2006 · Recalled
- 2 generations backK112173 Speacelabs Multigas ModuleSpacelabs Healthcare · 2011 · Recalled
- 1 generation backK121017 Capnography Pad (92516)Spacelabs Healthcare · 2012
- This deviceK130112 Capno Module, 92517Spacelabs Healthcare · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and… | Datex-Ohmeda | 2000 | — |
| −4 | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx… | GE Healthcare | 2005 | 2 |
| −3 | K053599 | Spacelabs Medical Multigas Analyzer Module 91518 and Accessories | Spacelabs Medical, Inc. | 2006 | 2 |
| −2 | K112173 | Speacelabs Multigas Module | Spacelabs Healthcare | 2011 | 1 |
| −1 | K121017 | Capnography Pad (92516) | Spacelabs Healthcare | 2012 | — |
| 0 (this device) | K130112 | Capno Module, 92517 | Spacelabs Healthcare | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 CCK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K121017 | Capnography Pad (92516)Summary page 1…98029 Spacelabs Healthcare Capno Module, 92517 CO 2 monitor Carbon dioxile gas analyzer 21 CFR §868.1400 CCK New Model Predicate 510(k) Number Spacelabs Healthcare K121017 Capno Module, 92517 §62 K136t MAR 2 1 2013 f" Predicate Manufacturer / Model Spacelabs Healthcare Capnography Pod (92516)… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 3 of the 6 ancestors have a recall of any class.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, 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 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
What is it indicated for?
The Capno Module, 92517 (92517) is intended to provide a means of monitoring carbon dioxide and respiration rate and alert clinical personnel when the concentration moves outside of user-defined limits.
The 92517 is intended to be used with and controlled by a Spacelabs Healthcare monitors. The 92517 is intended to be used for monitoring adult, pediatric and neonate patients, under the direction of qualified medical personnel.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130112: Capno Module, 92517.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130112
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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