510(k) · Cleared
Recalled · Class II · 2025CoSense 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 Jul 22, 2015 as substantially equivalent to K130036 (Capnia, Inc., 2014) after an 86-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 22, 2015
- Review
- 86 days
- Class
- Class II
- Product code
- CCJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000962 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK000962 Pico Smokerlyzer, Model EC-50Bedfont Scientific, Ltd. · 2000
- 3 generations backK080278 Tabataba CotesterFim Medical · 2008
- 2 generations backK121768 CosenseCapnia, Inc. · 2012
- 1 generation backK130036 Cosense CO MonitorCapnia, Inc. · 2014
- This deviceK151107 CoSense ETCO MonitorCapnia, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK253119 CoSense ETCO MonitorCapnia, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253119CoSense ETCO MonitorCapnia, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000962 | Pico Smokerlyzer, Model EC-50 | Bedfont Scientific, Ltd. | 2000 | — |
| −3 | K080278 | Tabataba Cotester | Fim Medical | 2008 | — |
| −2 | K121768 | Cosense | Capnia, Inc. | 2012 | — |
| −1 | K130036 | Cosense CO Monitor | Capnia, Inc. | 2014 | — |
| 0 (this device) | K151107 | CoSense ETCO Monitor | Capnia, Inc. | 2015 | — |
| +1 | K253119 | CoSense ETCO Monitor | Capnia, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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 K253119 CoSense ETCO Monitorscore 12.6 · 5 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 |
|---|---|---|---|
| * | K130036 | Cosense CO MonitorSummary page 4…Classification Name: Carbon Monoxide Gas Analyzer (21 CFR 868.1430, Product Code CCJ) Predicate Device: CoSense® ETCO Monitor (K130036) Device Description: The CoSense ETCO Monitor is a battery-operated carbon monoxide (CO) monito… | 2014 |
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 |
|---|---|---|---|
| K253119 | CoSense ETCO Monitor | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2025 | Class II | Z-2198-2025 | Device Design | Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K253119 (Capnia, Inc., 2026) has gone furthest, with 0 descendants of its own.
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. 2015, 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 is also for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation.
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/K151107 · printed Nov 5, 2026
Cite this page
510(k) Report. “K151107: CoSense ETCO Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K151107
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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