FDA product code QOV: Critical Care Ventilator
QOV is the FDA product code for critical care ventilator. It is a Not classified device, reviewed by the Ear, Nose and Throat panel. Devices under QOV reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas during emergency and/or transfer use. Device is intended to be used temporarily and/or in emergency situations during declared public health emergency.
Classification
| Field | Value |
|---|---|
| Device name | Critical Care Ventilator |
| Device class | Not classified |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QOV devices
openFDA lists no recalls for product code QOV.
Frequently asked questions
What is FDA product code QOV?
QOV is the FDA product code for critical care ventilator. It is a Not classified device, reviewed by the Ear, Nose and Throat panel.
What device class is QOV?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QOV
- Run a recall and safety report across every QOV manufacturer
- Watch product code QOV 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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