FDA product code NUI: Ultrasound, Infusion, System
NUI is the FDA product code for ultrasound, infusion, system. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Neurology panel. FDA has cleared 4 510(k) submissions under NUI. The average 510(k) review took 112 days (median 64).
Definition
For regional infusion of contrast materials into selected vessels in the neuro-vasculature. The device may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
Classification
| Field | Value |
|---|---|
| Device name | Ultrasound, Infusion, System |
| Device class | Class II |
| Regulation | 21 CFR 870.1200 |
| Review panel | NE — Neurology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NUI clearance
Top NUI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ekos Corp. | 4 | 2006-12-05 |
Most recent NUI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K062508 | Ekos Corp. | NEUROWAVE MICRO-INFUSION SYSTEM | 2006-12-05 | 99 |
| K053437 | Ekos Corp. | EKOS MICRO-INFUSION SYSTEM | 2006-01-06 | 28 |
| K051225 | Ekos Corp. | EKOS MICRO-INFUSION SYSTEM | 2005-06-10 | 29 |
| K041826 | Ekos Corp. | EKOS ULTRASOUND INFUSION SYSTEM | 2005-04-27 | 294 |
Recalls for NUI devices
openFDA lists no recalls for product code NUI.
Frequently asked questions
What is FDA product code NUI?
NUI is the FDA product code for ultrasound, infusion, system. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Neurology panel.
What device class is NUI?
Class II, regulation 21 CFR 870.1200. Typical premarket route: 510(k).
How long does a 510(k) take for product code NUI?
Across 4 cleared submissions the average was 112 days from receipt to decision (median 64).
Which companies have the most NUI clearances?
Ekos Corp. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code NUI
- Run a recall and safety report across every NUI manufacturer
- Watch product code NUI 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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