FDA product code NKU: Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed

NKU is the FDA product code for injector and syringe, angiographic, balloon inflation, reprocessed. It is a Class II device, regulated under 21 CFR 870.1650 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under NKU. The average 510(k) review took 170 days (median 170). FDA has posted 1 recall for NKU devices.

Classification

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

Top NKU applicants

Most recent NKU clearances

Recalls for NKU devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-08-08.

Frequently asked questions

What is FDA product code NKU?

NKU is the FDA product code for injector and syringe, angiographic, balloon inflation, reprocessed. It is a Class II device, regulated under 21 CFR 870.1650 and reviewed by the Cardiovascular panel.

What device class is NKU?

Class II, regulation 21 CFR 870.1650. Typical premarket route: 510(k).

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

Across 1 cleared submissions the average was 170 days from receipt to decision (median 170).

Which companies have the most NKU clearances?

Sterilmed, Inc. (1).

Have NKU devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2008-08-08.

Next steps

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