FDA product code KBY: Set, Filliform, Eustachian
KBY is the FDA product code for set, filliform, eustachian. It is a Class I device, regulated under 21 CFR 874.4175 and reviewed by the Ear, Nose and Throat panel. Devices under KBY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Set, Filliform, Eustachian |
| Device class | Class I |
| Regulation | 21 CFR 874.4175 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Recalls for KBY devices
openFDA lists no recalls for product code KBY.
Frequently asked questions
What is FDA product code KBY?
KBY is the FDA product code for set, filliform, eustachian. It is a Class I device, regulated under 21 CFR 874.4175 and reviewed by the Ear, Nose and Throat panel.
What device class is KBY?
Class I, regulation 21 CFR 874.4175. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KBY
- Run a recall and safety report across every KBY manufacturer
- Watch product code KBY 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