FDA product code QCX: Retrograde Intubation Set
QCX is the FDA product code for retrograde intubation set. It is a Class II device, regulated under 21 CFR 868.5095 and reviewed by the Anesthesiology panel. Devices under QCX reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A retrograde intubation device is a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles (21 CFR 8685090), syringe (21 CFR 880.5860), and hemostats (21 CFR 878.4800).
Classification
| Field | Value |
|---|---|
| Device name | Retrograde Intubation Set |
| Device class | Class II |
| Regulation | 21 CFR 868.5095 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for QCX devices
openFDA lists no recalls for product code QCX.
Frequently asked questions
What is FDA product code QCX?
QCX is the FDA product code for retrograde intubation set. It is a Class II device, regulated under 21 CFR 868.5095 and reviewed by the Anesthesiology panel.
What device class is QCX?
Class II, regulation 21 CFR 868.5095. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QCX
- Run a recall and safety report across every QCX manufacturer
- Watch product code QCX 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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