FDA product code CCJ: Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
CCJ is the FDA product code for analyzer, gas, carbon-monoxide, gaseous-phase. It is a Class II device, regulated under 21 CFR 868.1430 and reviewed by the Anesthesiology panel. FDA has cleared 28 510(k) submissions under CCJ, 1 in the last five years, from 20 different applicants. The average 510(k) review took 200 days (median 154); 247 days on average over the last three years. FDA has posted 1 recall for CCJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase |
| Device class | Class II |
| Regulation | 21 CFR 868.1430 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CCJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 140 |
| 2018 | 1 | 319 |
| 2019 | 1 | 546 |
| 2021 | 2 | 302 |
| 2026 | 1 | 247 |
Compare with all 510(k) review times · Search every CCJ clearance
Top CCJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bedfont Scientific, Ltd. | 5 | 2021-12-21 |
| Capnia, Inc. | 4 | 2026-05-29 |
| Vitalograph , Ltd. | 2 | 1989-05-05 |
| Carrot, Inc. | 1 | 2021-06-30 |
| MD Diagnostics Limited | 1 | 2018-03-02 |
15 more applicants have CCJ clearances. See the full list in Caduvo.
Most recent CCJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253119 | Capnia, Inc. | CoSense ETCO Monitor | 2026-05-29 | 247 |
| K211918 | Bedfont Scientific, Ltd. | iCOquit® Smokerlyzer® | 2021-12-21 | 183 |
| K201206 | Carrot, Inc. | Pivot Breath Sensor | 2021-06-30 | 422 |
| K173238 | Bedfont Scientific, Ltd. | ToxCO | 2019-04-04 | 546 |
| K171129 | MD Diagnostics Limited | CO Check Pro, CO Screen | 2018-03-02 | 319 |
Recalls for CCJ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-21.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code CCJ?
CCJ is the FDA product code for analyzer, gas, carbon-monoxide, gaseous-phase. It is a Class II device, regulated under 21 CFR 868.1430 and reviewed by the Anesthesiology panel.
What device class is CCJ?
Class II, regulation 21 CFR 868.1430. Typical premarket route: 510(k).
How long does a 510(k) take for product code CCJ?
Across 28 cleared submissions the average was 200 days from receipt to decision (median 154).
Which companies have the most CCJ clearances?
Bedfont Scientific, Ltd. (5); Capnia, Inc. (4); Vitalograph , Ltd. (2); Carrot, Inc. (1); MD Diagnostics Limited (1).
Have CCJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code CCJ
- Run a recall and safety report across every CCJ manufacturer
- Watch product code CCJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times