FDA product code CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CCK is the FDA product code for analyzer, gas, carbon-dioxide, gaseous-phase. It is a Class II device, regulated under 21 CFR 868.1400 and reviewed by the Anesthesiology panel. FDA has cleared 307 510(k) submissions under CCK, 16 in the last five years, from 158 different applicants. The average 510(k) review took 148 days (median 100); 355 days on average over the last three years. FDA has posted 84 recalls for CCK devices, 14 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Device class | Class II |
| Regulation | 21 CFR 868.1400 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CCK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 180 |
| 2018 | 6 | 322 |
| 2019 | 7 | 239 |
| 2020 | 4 | 172 |
| 2021 | 4 | 200 |
| 2022 | 3 | 217 |
| 2023 | 4 | 550 |
| 2024 | 3 | 679 |
| 2025 | 3 | 145 |
| 2026 | 3 | 240 |
Compare with all 510(k) review times · Search every CCK clearance
Top CCK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oridion Medical 1987 , Ltd. | 17 | 2020-04-27 |
| Nihon Kohden America, Inc. | 9 | 2009-03-02 |
| Datex Division Instrumentarium Corp. | 9 | 1994-08-01 |
| Salter Labs | 8 | 2016-03-10 |
| Ohmeda Medical | 6 | 1995-07-07 |
153 more applicants have CCK clearances. See the full list in Caduvo.
Most recent CCK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251641 | Nihon Kohden Corporation | GF-310R Multigas Unit (GF-310R) | 2026-08-12 | 440 |
| K261633 | Affirm Medical Technologies II, LLC | VisuBreath | 2026-07-14 | 57 |
| K253030 | Covidien, LLC | Capnostream35 Portable Respiratory Monitor (PM35MN) | 2026-05-01 | 224 |
| K250148 | Prior Care Science Technology, Ltd. | Medical Gas Analyzer (AG200) | 2025-08-28 | 219 |
| K243956 | Nihon Kohden Corporation | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | 2025-06-10 | 169 |
Recalls for CCK devices
84 product recalls in 36 recall events; 14 initiated in the last five years and 16 still open. Most recent: 2025-04-07.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 5 |
| 2019 | 8 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2025 | 13 |
Frequently asked questions
What is FDA product code CCK?
CCK is the FDA product code for analyzer, gas, carbon-dioxide, gaseous-phase. It is a Class II device, regulated under 21 CFR 868.1400 and reviewed by the Anesthesiology panel.
What device class is CCK?
Class II, regulation 21 CFR 868.1400. Typical premarket route: 510(k).
How long does a 510(k) take for product code CCK?
Across 307 cleared submissions the average was 148 days from receipt to decision (median 100).
Which companies have the most CCK clearances?
Oridion Medical 1987 , Ltd. (17); Nihon Kohden America, Inc. (9); Datex Division Instrumentarium Corp. (9); Salter Labs (8); Ohmeda Medical (6).
Have CCK devices been recalled?
Yes: 84 product recalls across 36 recall events; the most recent began 2025-04-07.
Next steps
- Run an FDA pathway report with predicate devices for product code CCK
- Run a recall and safety report across every CCK manufacturer
- Watch product code CCK 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.
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