FDA product code QKR: Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
QKR is the FDA product code for face mask within the scope of the face mask and barrier face covering enforcement policy or face mask umbrella eua. It is a Not classified device, reviewed by the General Hospital panel. Devices under QKR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for QKR devices.
Definition
Face mask is intended to be worn by general public or healthcare personnel and excludes air purifying respirators. The mask covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. The device is either subject to the Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance, or to the Face Mask Umbrella EUA, available at https://www.fda.gov/media/137121/download
Classification
| Field | Value |
|---|---|
| Device name | Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua |
| Device class | Not classified |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for QKR devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2020-07-21.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code QKR?
QKR is the FDA product code for face mask within the scope of the face mask and barrier face covering enforcement policy or face mask umbrella eua. It is a Not classified device, reviewed by the General Hospital panel.
What device class is QKR?
Not classified. Typical premarket route: 510(k) exempt.
Have QKR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-07-21.
Next steps
- Run an FDA pathway report with predicate devices for product code QKR
- Run a recall and safety report across every QKR manufacturer
- Watch product code QKR 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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