FDA product code QOR: Continuous Ventilator, Minimal Ventilatory Support
QOR is the FDA product code for continuous ventilator, minimal ventilatory support. It is a Not classified device, reviewed by the Anesthesiology panel. Devices under QOR reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
A continuous ventilator (respirator) for emergency use that is intended to provide minimal ventilatory support to mechanically control or assist patient breathing during declared public health emergency.
Classification
| Field | Value |
|---|---|
| Device name | Continuous Ventilator, Minimal Ventilatory Support |
| Device class | Not classified |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QOR devices
openFDA lists no recalls for product code QOR.
Frequently asked questions
What is FDA product code QOR?
QOR is the FDA product code for continuous ventilator, minimal ventilatory support. It is a Not classified device, reviewed by the Anesthesiology panel.
What device class is QOR?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QOR
- Run a recall and safety report across every QOR manufacturer
- Watch product code QOR 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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