FDA product code QLO: Immunoadsorption Column For Emergency Use
QLO is the FDA product code for immunoadsorption column for emergency use. It is a Not classified device, reviewed by the Gastroenterology and Urology panel. Devices under QLO reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Extracorporeal carbon dioxide removal from blood for use during declared public health emergency.
Classification
| Field | Value |
|---|---|
| Device name | Immunoadsorption Column For Emergency Use |
| Device class | Not classified |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for QLO devices
openFDA lists no recalls for product code QLO.
Frequently asked questions
What is FDA product code QLO?
QLO is the FDA product code for immunoadsorption column for emergency use. It is a Not classified device, reviewed by the Gastroenterology and Urology panel.
What device class is QLO?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QLO
- Run a recall and safety report across every QLO manufacturer
- Watch product code QLO 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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