FDA product code CCE: Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
CCE is the FDA product code for analyzer, gas, oxygen, partial pressure, blood-phase, indwelling. It is a Class II device, regulated under 21 CFR 868.1200 and reviewed by the Anesthesiology panel. FDA has cleared 23 510(k) submissions under CCE, from 16 different applicants. The average 510(k) review took 156 days (median 91).
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling |
| Device class | Class II |
| Regulation | 21 CFR 868.1200 |
| 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 CCE clearance
Top CCE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Bentley | 3 | 1988-02-12 |
| Baxter Healthcare Corp | 2 | 1991-08-13 |
| Shiley, Inc. | 2 | 1989-11-28 |
| C.R. Bard, Inc. | 2 | 1988-12-16 |
| Orange Medical Instruments, Inc. | 2 | 1986-03-13 |
11 more applicants have CCE clearances. See the full list in Caduvo.
Most recent CCE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935778 | Via Medical Corp. | VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM | 1996-12-05 | 1098 |
| K912145 | S & W Medico Teknik | SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA | 1992-05-05 | 392 |
| K910453 | Baxter Healthcare Corp | TOPS NEEDLE TIP PROBE & PVC TIP PROBE | 1991-08-13 | 193 |
| K905397 | Puritan Bennett Corp. | PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM | 1991-05-14 | 165 |
| K896311 | Optex Biomedical | OPTEX BLOOD GAS MONITORING SYSTEM | 1990-01-03 | 63 |
Recalls for CCE devices
openFDA lists no recalls for product code CCE.
Frequently asked questions
What is FDA product code CCE?
CCE is the FDA product code for analyzer, gas, oxygen, partial pressure, blood-phase, indwelling. It is a Class II device, regulated under 21 CFR 868.1200 and reviewed by the Anesthesiology panel.
What device class is CCE?
Class II, regulation 21 CFR 868.1200. Typical premarket route: 510(k).
How long does a 510(k) take for product code CCE?
Across 23 cleared submissions the average was 156 days from receipt to decision (median 91).
Which companies have the most CCE clearances?
American Bentley (3); Baxter Healthcare Corp (2); Shiley, Inc. (2); C.R. Bard, Inc. (2); Orange Medical Instruments, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code CCE
- Run a recall and safety report across every CCE manufacturer
- Watch product code CCE 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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