FDA product code QOT: Emergency Ventilator
QOT is the FDA product code for emergency ventilator. It is a Not classified device, reviewed by the Anesthesiology panel. Devices under QOT 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 | Emergency Ventilator |
| Device class | Not classified |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QOT devices
openFDA lists no recalls for product code QOT.
Frequently asked questions
What is FDA product code QOT?
QOT is the FDA product code for emergency ventilator. It is a Not classified device, reviewed by the Anesthesiology panel.
What device class is QOT?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QOT
- Run a recall and safety report across every QOT manufacturer
- Watch product code QOT 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.