FDA product code KQL: Tube, Tympanostomy With Semi-Permeable Membrane
KQL is the FDA product code for tube, tympanostomy with semi-permeable membrane. It is a Class II device, regulated under 21 CFR 874.3930 and reviewed by the Ear, Nose and Throat panel. Devices under KQL reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Tympanostomy With Semi-Permeable Membrane |
| Device class | Class II |
| Regulation | 21 CFR 874.3930 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for KQL devices
openFDA lists no recalls for product code KQL.
Frequently asked questions
What is FDA product code KQL?
KQL is the FDA product code for tube, tympanostomy with semi-permeable membrane. It is a Class II device, regulated under 21 CFR 874.3930 and reviewed by the Ear, Nose and Throat panel.
What device class is KQL?
Class II, regulation 21 CFR 874.3930. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code KQL
- Run a recall and safety report across every KQL manufacturer
- Watch product code KQL 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 Ear, Nose and Throat product codes · FDA product code lookup