510(k) · Cleared
ClearedCosense
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 Oct 31, 2012 as substantially equivalent to K080278 (Fim Medical, 2008) after a 138-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Oct 31, 2012
- Review
- 138 days
- Class
- Class II
- Product code
- CCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000962 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK000962 Pico Smokerlyzer, Model EC-50Bedfont Scientific, Ltd. · 2000
- 1 generation backK080278 Tabataba CotesterFim Medical · 2008
- This deviceK121768 CosenseCapnia, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK130036 Cosense CO MonitorCapnia, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK151107 CoSense ETCO MonitorCapnia, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 0 of its ownK253119 CoSense ETCO MonitorCapnia, Inc. · 2026
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 | K000962 | Pico Smokerlyzer, Model EC-50 | Bedfont Scientific, Ltd. | 2000 | — |
| −1 | K080278 | Tabataba Cotester | Fim Medical | 2008 | — |
| 0 (this device) | K121768 | Cosense | Capnia, Inc. | 2012 | — |
| +1 | K130036 | Cosense CO Monitor | Capnia, Inc. | 2014 | — |
| +2 | K151107 | CoSense ETCO Monitor | Capnia, Inc. | 2015 | 1 |
| +3 | K253119 | CoSense ETCO Monitor | Capnia, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K080278 | Tabataba CotesterSummary page 1…_CCJ, 868.1430 Predicate Device(s): The subject device is equivalent to the following devices: * FIM Medical Tabataba CO Tester (K080278) Device Description: The CoSense CQ Monitor isa battery-operated carbon monoxide monitor. It uses a… | 2008 |
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 |
|---|---|---|---|
| K130036 | Cosense CO Monitor | 2014 | 2 |
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 3 companies; a new generation was cleared every 8.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K130036 (Capnia, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K080278.
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. 2012, 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 CO Monitor is indicated for the monitoring of Carbon Monoxide from endogenous and exogenous sources in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It is for use by health professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121768: Cosense.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121768
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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