FDA product code KII: Tube, Cement Ventilation
KII is the FDA product code for tube, cement ventilation. It is a Class I device, regulated under 21 CFR 888.4230 and reviewed by the Orthopedic panel. Devices under KII reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Cement Ventilation |
| Device class | Class I |
| Regulation | 21 CFR 888.4230 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Recalls for KII devices
openFDA lists no recalls for product code KII.
Frequently asked questions
What is FDA product code KII?
KII is the FDA product code for tube, cement ventilation. It is a Class I device, regulated under 21 CFR 888.4230 and reviewed by the Orthopedic panel.
What device class is KII?
Class I, regulation 21 CFR 888.4230. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KII
- Run a recall and safety report across every KII manufacturer
- Watch product code KII 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.