FDA product code CCC: Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
CCC is the FDA product code for analyzer, gas, carbon-dioxide, partial pressure, blood-phase, indwelling. It is a Class II device, regulated under 21 CFR 868.1150 and reviewed by the Anesthesiology panel. FDA has cleared 15 510(k) submissions under CCC, from 11 different applicants. The average 510(k) review took 260 days (median 195).
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling |
| Device class | Class II |
| Regulation | 21 CFR 868.1150 |
| 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 CCC clearance
Top CCC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Optical Sensors, Inc. | 4 | 1997-04-09 |
| Diametrics Medical, Ltd. | 2 | 1999-11-23 |
| Alertis Medical AS | 1 | 2007-11-07 |
| Biomedical Sensors, Inc. | 1 | 1997-11-04 |
| Biomedical Sensors, Ltd. | 1 | 1995-11-13 |
6 more applicants have CCC clearances. See the full list in Caduvo.
Most recent CCC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K071165 | Alertis Medical AS | ISCALERT SENSOR SYSTEM | 2007-11-07 | 195 |
| K983198 | Diametrics Medical, Ltd. | TRENDCARE CALIBRATOR MODEL SCU 7007 | 1999-11-23 | 438 |
| K972314 | Diametrics Medical, Ltd. | PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM | 1997-12-19 | 182 |
| K953893 | Biomedical Sensors, Inc. | PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM | 1997-11-04 | 810 |
| K961790 | Optical Sensors, Inc. | POINT-OF-CARE BLOOD GAS MONITOR SYSTEM | 1997-04-09 | 335 |
Recalls for CCC devices
openFDA lists no recalls for product code CCC.
Frequently asked questions
What is FDA product code CCC?
CCC is the FDA product code for analyzer, gas, carbon-dioxide, partial pressure, blood-phase, indwelling. It is a Class II device, regulated under 21 CFR 868.1150 and reviewed by the Anesthesiology panel.
What device class is CCC?
Class II, regulation 21 CFR 868.1150. Typical premarket route: 510(k).
How long does a 510(k) take for product code CCC?
Across 15 cleared submissions the average was 260 days from receipt to decision (median 195).
Which companies have the most CCC clearances?
Optical Sensors, Inc. (4); Diametrics Medical, Ltd. (2); Alertis Medical AS (1); Biomedical Sensors, Inc. (1); Biomedical Sensors, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CCC
- Run a recall and safety report across every CCC manufacturer
- Watch product code CCC 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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