510(k) · Cleared
ClearedCO Check Pro, CO Screen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MD Diagnostics Limited · CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Cleared on Mar 2, 2018 as substantially equivalent to K080278 (Fim Medical, 2008) and 1 other predicate after a 319-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Mar 2, 2018
- Review
- 319 days
- Class
- Class II
- Product code
- CCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000962 (2000). 3 ancestors in all, the oldest K950197 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000962 | Pico Smokerlyzer, Model EC-50 | Bedfont Scientific, Ltd. | 2000 | — |
| −1 | K080278 | Tabataba Cotester | Fim Medical | 2008 | — |
| 0 (this device) | K171129 | CO Check Pro, CO Screen | MD Diagnostics Limited | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 |
|---|---|---|---|
| * | K080278 | Tabataba CotesterSummary page 4…30. Device classification: II Product code: CCJ Classification Panel: Anesthesiology Predicate Device details Predicate 1: Device name / 510k: TABATABA CO TESTER (k080278) Manufacturer: FIM Medical, France. Predicate 2: Device name / 510k: MicroCO meter (k950197)… | 2008 |
| * | K950197 | MicrocoSummary page 4…edicate Device details Predicate 1: Device name / 510k: TABATABA CO TESTER (k080278) Manufacturer: FIM Medical, France. Predicate 2: Device name / 510k: MicroCO meter (k950197) 45 K171129… | 1996 |
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K080278.
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. 2018, 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?
For monitoring of carbon monoxide in adult exhaled breath. They are for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. Also can be used for ambient air monitoring. For use by healthcare professionals only in professional healthcare facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171129: CO Check Pro, CO Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171129
Report an extraction error
Are you the manufacturer?
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