FDA product code CBD: Bottle, Collection, Breathing System (Calibrated)
CBD is the FDA product code for bottle, collection, breathing system (calibrated). 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 CBD, from 3 different applicants. The average 510(k) review took 94 days (median 7).
Classification
| Field | Value |
|---|---|
| Device name | Bottle, Collection, Breathing System (Calibrated) |
| 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 CBD clearance
Top CBD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lkb Instruments, Inc. | 1 | 1978-11-27 |
| Mcgaw Respiratory Therapy | 1 | 1977-04-15 |
| Diemolding Corp. | 1 | 1977-03-01 |
Most recent CBD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K780340 | Lkb Instruments, Inc. | IMV SYSTEM | 1978-11-27 | 271 |
| K770665 | Mcgaw Respiratory Therapy | VALVE, PRESSURE, DEMAND | 1977-04-15 | 7 |
| K770369 | Diemolding Corp. | VACON TM | 1977-03-01 | 5 |
Recalls for CBD devices
openFDA lists no recalls for product code CBD.
Frequently asked questions
What is FDA product code CBD?
CBD is the FDA product code for bottle, collection, breathing system (calibrated). It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel.
What device class is CBD?
Class II, regulation 21 CFR 880.6740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CBD?
Across 3 cleared submissions the average was 94 days from receipt to decision (median 7).
Which companies have the most CBD clearances?
Lkb Instruments, Inc. (1); Mcgaw Respiratory Therapy (1); Diemolding Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CBD
- Run a recall and safety report across every CBD manufacturer
- Watch product code CBD 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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