FDA product code NII: Disinfectant, Dialysate Delivery System

NII is the FDA product code for disinfectant, dialysate delivery system. It is a Class II device, regulated under 21 CFR 876.5860 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under NII, from 2 different applicants. The average 510(k) review took 459 days (median 459).

Definition

Disinfectant intended for reprocessing dialysate delivery systems.

Classification

Compare with all 510(k) review times · Search every NII clearance

Top NII applicants

Most recent NII clearances

Recalls for NII devices

openFDA lists no recalls for product code NII.

Frequently asked questions

What is FDA product code NII?

NII is the FDA product code for disinfectant, dialysate delivery system. It is a Class II device, regulated under 21 CFR 876.5860 and reviewed by the General Hospital panel.

What device class is NII?

Class II, regulation 21 CFR 876.5860. Typical premarket route: 510(k).

How long does a 510(k) take for product code NII?

Across 2 cleared submissions the average was 459 days from receipt to decision (median 459).

Which companies have the most NII clearances?

Ge Infrastructure Water & Process Technologies (1); Krd Co., Ltd. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code NII
• Run a recall and safety report across every NII manufacturer
• Watch product code NII 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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