FDA product code KQR: Detector, Air Or Foam
KQR is the FDA product code for detector, air or foam. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. Devices under KQR reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Detector, Air Or Foam |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Recalls for KQR devices
openFDA lists no recalls for product code KQR.
Frequently asked questions
What is FDA product code KQR?
KQR is the FDA product code for detector, air or foam. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is KQR?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code KQR
- Run a recall and safety report across every KQR manufacturer
- Watch product code KQR 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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