FDA product code FKE: Tie, Dialysis
FKE is the FDA product code for tie, dialysis. It is a Class I device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. Devices under FKE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Tie, Dialysis |
| Device class | Class I |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for FKE devices
openFDA lists no recalls for product code FKE.
Frequently asked questions
What is FDA product code FKE?
FKE is the FDA product code for tie, dialysis. It is a Class I device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FKE?
Class I, regulation 21 CFR 876.5820. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FKE
- Run a recall and safety report across every FKE manufacturer
- Watch product code FKE 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 Gastroenterology and Urology product codes · FDA product code lookup