FDA product code CCI: Analyzer, Gas, Nitrogen, Gaseous-Phase
CCI is the FDA product code for analyzer, gas, nitrogen, gaseous-phase. It is a Class II device, regulated under 21 CFR 868.1690 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under CCI, from 2 different applicants. The average 510(k) review took 159 days (median 159).
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Nitrogen, Gaseous-Phase |
| Device class | Class II |
| Regulation | 21 CFR 868.1690 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CCI clearance
Top CCI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Datascope Corp. | 1 | 1988-03-31 |
| Mcgaw Respiratory Therapy | 1 | 1977-08-16 |
Most recent CCI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872024 | Datascope Corp. | CO2/02 MONITOR MULTINEX | 1988-03-31 | 310 |
| K771516 | Mcgaw Respiratory Therapy | CAPILLARY SAMPLE LINE | 1977-08-16 | 8 |
Recalls for CCI devices
openFDA lists no recalls for product code CCI.
Frequently asked questions
What is FDA product code CCI?
CCI is the FDA product code for analyzer, gas, nitrogen, gaseous-phase. It is a Class II device, regulated under 21 CFR 868.1690 and reviewed by the Anesthesiology panel.
What device class is CCI?
Class II, regulation 21 CFR 868.1690. Typical premarket route: 510(k).
How long does a 510(k) take for product code CCI?
Across 2 cleared submissions the average was 159 days from receipt to decision (median 159).
Which companies have the most CCI clearances?
Datascope Corp. (1); Mcgaw Respiratory Therapy (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CCI
- Run a recall and safety report across every CCI manufacturer
- Watch product code CCI 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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