FDA product code QKY: Decontamination Systems For N95 Respirators
QKY is the FDA product code for decontamination systems for n95 respirators. It is a Not classified device, reviewed by the General Hospital panel. Devices under QKY reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for QKY devices.
Definition
Device intended to decontaminate compatible N95 or N95-equivalent respirators for their reuse by healthcare professionals during the declared public health emergency.
Classification
| Field | Value |
|---|---|
| Device name | Decontamination Systems For N95 Respirators |
| Device class | Not classified |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QKY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-08-13.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code QKY?
QKY is the FDA product code for decontamination systems for n95 respirators. It is a Not classified device, reviewed by the General Hospital panel.
What device class is QKY?
Not classified. Typical premarket route: PMA.
Have QKY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-08-13.
Next steps
- Run an FDA pathway report with predicate devices for product code QKY
- Run a recall and safety report across every QKY manufacturer
- Watch product code QKY 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times