510(k) · Cleared
ClearedToxCO
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 4, 2019 as substantially equivalent to K082315 (Bedfont Scientific, Ltd., 2010) after a 546-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Apr 4, 2019
- Review
- 546 days
- Class
- Class II
- Product code
- CCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082315 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK082315 EC50 Micro+ SmokerlyzerBedfont Scientific, Ltd. · 2010
- This deviceK173238 ToxCOBedfont Scientific, Ltd. · 2019
View 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) | K173238 | ToxCO | Bedfont Scientific, Ltd. | 2019 | — |
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.
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K082315.
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. 2019, 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 ToxCO® breath Carbon Monoxide monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173238: ToxCO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173238
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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