FDA product code QLN: Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19

QLN is the FDA product code for extracorporeal system for carbon dioxide removal for the treatment of covid-19. It is a Not classified device, reviewed by the Cardiovascular panel. Devices under QLN reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for QLN devices.

Definition

to treat lung failure due to COVID-19 when used as an adjunct to noninvasive or invasive mechanical ventilation in reducing hypercapnia and hypercapnic acidosis due to Coronavirus Disease 2019 (COVID-19), and/or maintaining normalized levels of partial pressure of carbon dioxide (PCO2) and pH in patients suffering from acute, reversible respiratory failure due to COVID-19 for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved.

Classification

Recalls for QLN devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-12-18.

Frequently asked questions

What is FDA product code QLN?

QLN is the FDA product code for extracorporeal system for carbon dioxide removal for the treatment of covid-19. It is a Not classified device, reviewed by the Cardiovascular panel.

What device class is QLN?

Not classified. Typical premarket route: PMA.

Have QLN devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2020-12-18.

Next steps

• Run an FDA pathway report with predicate devices for product code QLN
• Run a recall and safety report across every QLN manufacturer
• Watch product code QLN 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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