510(k) · Cleared
ClearedCoSense ETCO Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Capnia, Inc. · CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Cleared on May 29, 2026 as substantially equivalent to K151107 (Capnia, Inc., 2015) after a 247-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- May 29, 2026
- Review
- 247 days
- Class
- Class II
- Product code
- CCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000962 (2000). No later device cites it as a predicate yet.
- Root · 5 generations backK000962 Pico Smokerlyzer, Model EC-50Bedfont Scientific, Ltd. · 2000
- 4 generations backK080278 Tabataba CotesterFim Medical · 2008
- 3 generations backK121768 CosenseCapnia, Inc. · 2012
- 2 generations backK130036 Cosense CO MonitorCapnia, Inc. · 2014
- 1 generation backK151107 CoSense ETCO MonitorCapnia, Inc. · 2015 · Recalled
- This deviceK253119 CoSense ETCO MonitorCapnia, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000962 | Pico Smokerlyzer, Model EC-50 | Bedfont Scientific, Ltd. | 2000 | — |
| −4 | K080278 | Tabataba Cotester | Fim Medical | 2008 | — |
| −3 | K121768 | Cosense | Capnia, Inc. | 2012 | — |
| −2 | K130036 | Cosense CO Monitor | Capnia, Inc. | 2014 | — |
| −1 | K151107 | CoSense ETCO Monitor | Capnia, Inc. | 2015 | 1 |
| 0 (this device) | K253119 | CoSense ETCO Monitor | Capnia, Inc. | 2026 | — |
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 CCJ? 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 CCJ device
- #1 K211918 iCOquit® Smokerlyzer®score 2.8 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K151107 | CoSense ETCO MonitorSummary page 5…21 CFR 807.92(a)(3) Primary Predicate Predicate Manufacturer: Capnia, Inc. Predicate Trade Name: CoSense ETCO Monitor Predicate 510(k): K151107 No secondary predicate or reference device was used in this submission. 510(k) Summary… | 2015 |
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 26 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All CCJ devicesCCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · CCJ
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · CCJ
Too few CCJ 510(k)s in any year since 2007 to give a median.
Recalls per year · CCJ
No recall names CCJ since 2007.
Adverse event reports per year · CCJ
No MAUDE report names CCJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CoSense ETCO Monitor is indicated for the monitoring of carbon monoxide from endogenous sources (including hemolysis) and exogenous sources (including CO poisoning and smoke inhalation) in exhaled breath. The end-tidal carbon monoxide level can be used for the monitoring of carbon monoxide in medical conditions in which the rate of hemolysis may be relevant. It can be used with the pediatric population. It is also for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253119: CoSense ETCO Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253119
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026