510(k) · Cleared
ClearedPico Smokerlyzer, Model EC-50
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 Apr 20, 2000 after a 27-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Apr 20, 2000
- Review
- 27 days
- Class
- Class II
- Product code
- CCJ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK000962 Pico Smokerlyzer, Model EC-50Bedfont Scientific, Ltd. · 2000
- Descendant · cites it directly · 5 of its ownK080278 Tabataba CotesterFim Medical · 2008
- Descendant · 2 generations on · 3 of its ownK121768 CosenseCapnia, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK130036 Cosense CO MonitorCapnia, Inc. · 2014
- Descendant · 4 generations on · 1 of its ownK151107 CoSense ETCO MonitorCapnia, Inc. · 2015 · Recalled
- Descendant · 5 generations on · 0 of its ownK253119 CoSense ETCO MonitorCapnia, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K080278Tabataba CotesterFim Medical · 2008 · cites it directly5descendants
- K121768CosenseCapnia, Inc. · 2012 · 2 generations on3descendants
- K130036Cosense CO MonitorCapnia, Inc. · 2014 · 3 generations on2descendants
- K151107CoSense ETCO MonitorCapnia, Inc. · 2015 · 4 generations on1descendant
- K253119CoSense ETCO MonitorCapnia, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000962 | Pico Smokerlyzer, Model EC-50 | Bedfont Scientific, Ltd. | 2000 | — |
| +1 | K080278 | Tabataba Cotester | Fim Medical | 2008 | — |
| +2 | K121768 | Cosense | Capnia, Inc. | 2012 | — |
| +3 | K130036 | Cosense CO Monitor | Capnia, Inc. | 2014 | — |
| +4 | K151107 | CoSense ETCO Monitor | Capnia, Inc. | 2015 | 1 |
| +5 | K253119 | CoSense ETCO Monitor | Capnia, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 1 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
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, K080278 (Fim Medical, 2008) has gone furthest, with 5 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.
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/K000962 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000962: Pico Smokerlyzer, Model EC-50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000962
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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