FDA product code CBA: Monitor, Air Embolism, Ultrasonic
CBA is the FDA product code for monitor, air embolism, ultrasonic. It is a Class II device, regulated under 21 CFR 868.2025 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under CBA. The average 510(k) review took 83 days (median 83).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Air Embolism, Ultrasonic |
| Device class | Class II |
| Regulation | 21 CFR 868.2025 |
| 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 CBA clearance
Top CBA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Omp Laboratories, Inc. | 1 | 1978-07-17 |
Most recent CBA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K780703 | Omp Laboratories, Inc. | CUFF PACER | 1978-07-17 | 83 |
Recalls for CBA devices
openFDA lists no recalls for product code CBA.
Frequently asked questions
What is FDA product code CBA?
CBA is the FDA product code for monitor, air embolism, ultrasonic. It is a Class II device, regulated under 21 CFR 868.2025 and reviewed by the Anesthesiology panel.
What device class is CBA?
Class II, regulation 21 CFR 868.2025. Typical premarket route: 510(k).
How long does a 510(k) take for product code CBA?
Across 1 cleared submissions the average was 83 days from receipt to decision (median 83).
Which companies have the most CBA clearances?
Omp Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CBA
- Run a recall and safety report across every CBA manufacturer
- Watch product code CBA 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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