FDA product code QKU: Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)

QKU is the FDA product code for non-niosh-approved disposable filtering facepiece respirators (ffrs). It is a Not classified device, reviewed by the General Hospital panel. Devices under QKU reach the market by PMA; FDA lists no cleared 510(k)s for it.

Definition

For use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak (see: https://www.fda.gov/media/136403/download) (also see: https://www.fda.gov/media/136664/download). *This excludes NIOSH-approved respirators that are under EUA *This includes authorized KN95s from China under EUA *This excludes KN95s imported under enforcement discretion that don’t have EUA *This includes all authorized non-NIOSH-approved FFRs under EUA

Classification

Recalls for QKU devices

openFDA lists no recalls for product code QKU.

Frequently asked questions

What is FDA product code QKU?

QKU is the FDA product code for non-niosh-approved disposable filtering facepiece respirators (ffrs). It is a Not classified device, reviewed by the General Hospital panel.

What device class is QKU?

Not classified. Typical premarket route: PMA.

Next steps

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