FDA product code KBI: Bougie, Eustachian

KBI is the FDA product code for bougie, eustachian. It is a Class I device, regulated under 21 CFR 874.4175 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under KBI. The average 510(k) review took 18 days (median 18).

Classification

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

Top KBI applicants

Most recent KBI clearances

Recalls for KBI devices

openFDA lists no recalls for product code KBI.

Frequently asked questions

What is FDA product code KBI?

KBI is the FDA product code for bougie, eustachian. It is a Class I device, regulated under 21 CFR 874.4175 and reviewed by the Ear, Nose and Throat panel.

What device class is KBI?

Class I, regulation 21 CFR 874.4175. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 18 days from receipt to decision (median 18).

Which companies have the most KBI clearances?

V. Mueller O.V. Baxter Healthcare Corp. (1).

Next steps

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