FDA product code QOP: Respiratory Humidifier For Emergency Use
QOP is the FDA product code for respiratory humidifier for emergency use. It is a Not classified device, reviewed by the Ear, Nose and Throat panel. Devices under QOP reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device for use during declared public health emergency.
Classification
| Field | Value |
|---|---|
| Device name | Respiratory Humidifier For Emergency Use |
| Device class | Not classified |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QOP devices
openFDA lists no recalls for product code QOP.
Frequently asked questions
What is FDA product code QOP?
QOP is the FDA product code for respiratory humidifier for emergency use. It is a Not classified device, reviewed by the Ear, Nose and Throat panel.
What device class is QOP?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QOP
- Run a recall and safety report across every QOP manufacturer
- Watch product code QOP 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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