FDA product code QFB: Isocapnic Ventilation Device
QFB is the FDA product code for isocapnic ventilation device. It is a Class II device, regulated under 21 CFR 868.5480 and reviewed by the Anesthesiology panel. Devices under QFB reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags (21 CFR 868.5320), oxygen cannulas (21 CFR 868.5340), masks (21 CFR 868.5550), valves (21 CFR 868.5870), resuscitation bags (21 CFR 868.5915), and/or tubing (21 CFR 868.5925).
Classification
| Field | Value |
|---|---|
| Device name | Isocapnic Ventilation Device |
| Device class | Class II |
| Regulation | 21 CFR 868.5480 |
| Review panel | AN — Anesthesiology |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for QFB devices
openFDA lists no recalls for product code QFB.
Frequently asked questions
What is FDA product code QFB?
QFB is the FDA product code for isocapnic ventilation device. It is a Class II device, regulated under 21 CFR 868.5480 and reviewed by the Anesthesiology panel.
What device class is QFB?
Class II, regulation 21 CFR 868.5480. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QFB
- Run a recall and safety report across every QFB manufacturer
- Watch product code QFB 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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