510(k) · Cleared
ClearedEC50 Toxco+ Breath Carbon Monoxide Monitor
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 21, 2008 as substantially equivalent to K892841 (Bedfont Technical Instruments, Ltd., 1989) and 1 other predicate after a 391-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Feb 21, 2008
- Review
- 391 days
- Class
- Class II
- Product code
- CCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K892841 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK892841 Bedfont EC50 Smokerlyzer Carbon Monoxide MonitorBedfont Technical Instruments, Ltd. · 1989
- This deviceK070259 EC50 Toxco+ Breath Carbon Monoxide MonitorBedfont Scientific, Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892841 | Bedfont EC50 Smokerlyzer Carbon Monoxide Monitor | Bedfont Technical Instruments, Ltd. | 1989 | — |
| 0 (this device) | K070259 | EC50 Toxco+ Breath Carbon Monoxide Monitor | Bedfont Scientific, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K892841 | Bedfont EC50 Smokerlyzer Carbon Monoxide MonitorSummary page 1…al Equivalence: Manufacturer Trade Name 510(k) Number Bedfont Scientific Smokerlyzer K892841 Bedfont Scientific piCO Smokerlyzer K000962 7.2 Substantial Equivalence The Bedfont EC50… | 1989 |
| * | K000962 | Pico Smokerlyzer, Model EC-50Summary page 1…510(k) Number Bedfont Scientific Smokerlyzer K892841 Bedfont Scientific piCO Smokerlyzer K000962 7.2 Substantial Equivalence The Bedfont EC50 ToxCO+, Bedfont piCO and Bedfont Smokerlyzer products are all part of the EC50… | 2000 |
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?
- None of the 2 ancestors has a recall.
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 EC50 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/K070259 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070259: EC50 Toxco+ Breath Carbon Monoxide Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070259
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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