FDA product code KCI: Trocar, Tracheal
KCI is the FDA product code for trocar, tracheal. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. Devices under KCI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Trocar, Tracheal |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Recalls for KCI devices
openFDA lists no recalls for product code KCI.
Frequently asked questions
What is FDA product code KCI?
KCI is the FDA product code for trocar, tracheal. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is KCI?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KCI
- Run a recall and safety report across every KCI manufacturer
- Watch product code KCI 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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