510(k) · Cleared
ClearedCarbon Monoxide Breath Sensor System (COBSS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carrot Sense, Inc. · CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Cleared on Sep 29, 2017 as substantially equivalent to K082315 (Bedfont Scientific, Ltd., 2010) after a 140-day review. Its family tree reaches back 1 generation to 2010. 2 later devices descend from it.
- Decided
- Sep 29, 2017
- Review
- 140 days
- Class
- Class II
- Product code
- CCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082315 (2010). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK082315 EC50 Micro+ SmokerlyzerBedfont Scientific, Ltd. · 2010
- This deviceK171408 Carbon Monoxide Breath Sensor System (COBSS)Carrot Sense, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK211918 iCOquit® Smokerlyzer®Bedfont Scientific, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK201206 Pivot Breath SensorCarrot, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082315 | EC50 Micro+ Smokerlyzer | Bedfont Scientific, Ltd. | 2010 | — |
| 0 (this device) | K171408 | Carbon Monoxide Breath Sensor System (COBSS) | Carrot Sense, Inc. | 2017 | — |
| +1 | K211918 | iCOquit® Smokerlyzer® | Bedfont Scientific, Ltd. | 2021 | — |
| +1 | K201206 | Pivot Breath Sensor | Carrot, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 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 |
|---|---|---|---|
| * | K082315 | EC50 Micro+ SmokerlyzerSummary page 4…Product Code: CCJ Predicate Device Company: Bedfont Scientific LTD. Device Name: Micro+ Smokerlyzer 510(k) Number: K082315 Regulation: 868.1430 Product Codes: CCJ Device Description The Carbon Monoxide Breath Sensor Syste… | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2017, 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 Carbon Monoxide Breath Sensor System (COBSS) is a breath carbon monoxide monitor intended for single-user use
by cigarette smokers in smoking cessation programs to inform the user about how breath carbon monoxide levels are
affected by smoking behavior. The device is not intended to be used with other inhaled products.
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/K171408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171408: Carbon Monoxide Breath Sensor System (COBSS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171408
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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