FDA product code CBC: Bottle, Collection And Trap, Breathing System (Uncalibrated)
CBC is the FDA product code for bottle, collection and trap, breathing system (uncalibrated). It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under CBC, from 3 different applicants. The average 510(k) review took 100 days (median 77).
Classification
| Field | Value |
|---|---|
| Device name | Bottle, Collection And Trap, Breathing System (Uncalibrated) |
| Device class | Class II |
| Regulation | 21 CFR 880.6740 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CBC clearance
Top CBC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bird Products Corp. | 1 | 1993-05-13 |
| Narco Air-Shields | 1 | 1979-03-23 |
| Inspiron Corp. | 1 | 1976-07-16 |
Most recent CBC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K925422 | Bird Products Corp. | BIRD 1000 PV PORTABLE VENTILATOR | 1993-05-13 | 198 |
| K790035 | Narco Air-Shields | AMBU SUCTION BOOSTER | 1979-03-23 | 77 |
| K760082 | Inspiron Corp. | BOTTLE, CONDENSATE (#1628) | 1976-07-16 | 25 |
Recalls for CBC devices
openFDA lists no recalls for product code CBC.
Frequently asked questions
What is FDA product code CBC?
CBC is the FDA product code for bottle, collection and trap, breathing system (uncalibrated). It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel.
What device class is CBC?
Class II, regulation 21 CFR 880.6740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CBC?
Across 3 cleared submissions the average was 100 days from receipt to decision (median 77).
Which companies have the most CBC clearances?
Bird Products Corp. (1); Narco Air-Shields (1); Inspiron Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CBC
- Run a recall and safety report across every CBC manufacturer
- Watch product code CBC 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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