510(k) · Cleared
ClearedEC50 Micro+ Smokerlyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bedfont Scientific, Ltd. · CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Cleared on Feb 1, 2010 after a 537-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 1, 2010
- Review
- 537 days
- Class
- Class II
- Product code
- CCJ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK082315 EC50 Micro+ SmokerlyzerBedfont Scientific, Ltd. · 2010
- Descendant · cites it directly · 2 of its ownK171408 Carbon Monoxide Breath Sensor System (COBSS)Carrot Sense, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK211918 iCOquit® Smokerlyzer®Bedfont Scientific, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK201206 Pivot Breath SensorCarrot, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK173238 ToxCOBedfont Scientific, Ltd. · 2019
Most influential descendants
Showing 4 of 4 · See all- K171408Carbon Monoxide Breath Sensor System (COBSS)Carrot Sense, Inc. · 2017 · cites it directly2descendants
- K211918iCOquit® Smokerlyzer®Bedfont Scientific, Ltd. · 2021 · 2 generations on0descendants
- K201206Pivot Breath SensorCarrot, Inc. · 2021 · 2 generations on0descendants
- K173238ToxCOBedfont Scientific, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082315 | EC50 Micro+ Smokerlyzer | Bedfont Scientific, Ltd. | 2010 | — |
| +1 | K171408 | Carbon Monoxide Breath Sensor System (COBSS) | Carrot Sense, Inc. | 2017 | — |
| +2 | K211918 | iCOquit® Smokerlyzer® | Bedfont Scientific, Ltd. | 2021 | — |
| +2 | K201206 | Pivot Breath Sensor | Carrot, Inc. | 2021 | — |
| +1 | K173238 | ToxCO | Bedfont Scientific, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K171408 (Carrot Sense, Inc., 2017) has gone furthest, with 2 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. 2010, 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 | — |
https://510kreport.com/device/K082315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082315: EC50 Micro+ Smokerlyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082315
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026