510(k) · Cleared
ClearedTabataba Cotester
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fim Medical · CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Cleared on Nov 28, 2008 as substantially equivalent to K000962 (Bedfont Scientific, Ltd., 2000) after a 298-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Nov 28, 2008
- Review
- 298 days
- Class
- Class II
- Product code
- CCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000962 (2000). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000962 Pico Smokerlyzer, Model EC-50Bedfont Scientific, Ltd. · 2000
- This deviceK080278 Tabataba CotesterFim Medical · 2008
- Descendant · cites it directly · 3 of its ownK121768 CosenseCapnia, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK130036 Cosense CO MonitorCapnia, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK151107 CoSense ETCO MonitorCapnia, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 0 of its ownK253119 CoSense ETCO MonitorCapnia, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK171129 CO Check Pro, CO ScreenMD Diagnostics Limited · 2018
Most influential descendants
Showing 5 of 5 · See all- K121768CosenseCapnia, Inc. · 2012 · cites it directly3descendants
- K130036Cosense CO MonitorCapnia, Inc. · 2014 · 2 generations on2descendants
- K151107CoSense ETCO MonitorCapnia, Inc. · 2015 · 3 generations on1descendant
- K253119CoSense ETCO MonitorCapnia, Inc. · 2026 · 4 generations on0descendants
- K171129CO Check Pro, CO ScreenMD Diagnostics Limited · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000962 | Pico Smokerlyzer, Model EC-50 | Bedfont Scientific, Ltd. | 2000 | — |
| 0 (this device) | K080278 | Tabataba Cotester | Fim Medical | 2008 | — |
| +1 | K121768 | Cosense | Capnia, Inc. | 2012 | — |
| +2 | K130036 | Cosense CO Monitor | Capnia, Inc. | 2014 | — |
| +3 | K151107 | CoSense ETCO Monitor | Capnia, Inc. | 2015 | 1 |
| +4 | K253119 | CoSense ETCO Monitor | Capnia, Inc. | 2026 | — |
| +1 | K171129 | CO Check Pro, CO Screen | MD Diagnostics Limited | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K000962 | Pico Smokerlyzer, Model EC-50Summary page 1…sification Names: Carbon monoxide gas analyzer. Product Code CCJ, Regulation number 868.1430 Common/Usual Name: CO Analyzer 2. Equivalent legally marketed devices K000962. PiCO Smokerlyzer, Bedfont Scientific Ltd. 3. Indications for Use (intended use) The TABATABAS CO TESTER is for the monito… | 2000 |
What descends from it? (5)
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. 2008, 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 TABATABA® CO TESTER is for the monitoring of Carbon Monoxide 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 can also be used for ambient air monitoring. It is for use by health professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080278: Tabataba Cotester.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080278
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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