510(k) · Cleared
ClearedCapnography Pad (92516)
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 Jul 13, 2012 as substantially equivalent to K112173 (Spacelabs Healthcare, 2011) after a 100-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Jul 13, 2012
- Review
- 100 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001814 (2000). 5 ancestors in all, the oldest K954962 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK001814 Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01)…Datex-Ohmeda · 2000
- 3 generations backK051092 Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx)…GE Healthcare · 2005 · Recalled
- 2 generations backK053599 Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesSpacelabs Medical, Inc. · 2006 · Recalled
- 1 generation backK112173 Speacelabs Multigas ModuleSpacelabs Healthcare · 2011 · Recalled
- This deviceK121017 Capnography Pad (92516)Spacelabs Healthcare · 2012
- Descendant · cites it directly · 0 of its ownK130112 Capno Module, 92517Spacelabs Healthcare · 2013
Most influential descendants
Showing 1 of 1 · See all- K130112Capno Module, 92517Spacelabs Healthcare · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and… | Datex-Ohmeda | 2000 | — |
| −3 | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx… | GE Healthcare | 2005 | 2 |
| −2 | K053599 | Spacelabs Medical Multigas Analyzer Module 91518 and Accessories | Spacelabs Medical, Inc. | 2006 | 2 |
| −1 | K112173 | Speacelabs Multigas Module | Spacelabs Healthcare | 2011 | 1 |
| 0 (this device) | K121017 | Capnography Pad (92516) | Spacelabs Healthcare | 2012 | — |
| +1 | 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 |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K112173 | Speacelabs Multigas ModuleSummary page 1…2516) . CO; monitor Carbon dioxide gas analyzer 21 CFR §868.1400 CCK New Spacelabs Model Predicate Predicate 310(k) Number Manufacturer / Model Spacelabs Healthcare K112173 Spacelabs Multigas Capnography Pod (92516) Module, Model 92518 Fage [ af 4 Device Description: Intended Use:… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130112 | Capno Module, 92517 | 2013 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K130112 (Spacelabs Healthcare, 2013) has gone furthest, with 0 descendants of its own.
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. 2012, 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 Spacelabs Healthcare Capnography Pod, Model 92516 (CapnoPod) 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 CapnoPod is intended to be used with and controlled by a Spacelabs Healthcare monitors. The CapnoPod 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/K121017 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121017: Capnography Pad (92516).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121017
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