FDA product code NIO: Stent, Iliac
NIO is the FDA product code for stent, iliac. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NIO reach the market by PMA; FDA lists no cleared 510(k)s for it. 15 PMA applications cite this product code. FDA has posted 7 recalls for NIO devices, 2 initiated in the last five years.
Definition
Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen
Classification
| Field | Value |
|---|---|
| Device name | Stent, Iliac |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for NIO devices
7 product recalls in 6 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2025-03-04.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code NIO?
NIO is the FDA product code for stent, iliac. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is NIO?
Class III. Typical premarket route: PMA.
Have NIO devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2025-03-04.
Next steps
- Run an FDA pathway report with predicate devices for product code NIO
- Run a recall and safety report across every NIO manufacturer
- Watch product code NIO 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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