FDA product code KCG: Dilator, Tracheal

KCG is the FDA product code for dilator, tracheal. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under KCG. The average 510(k) review took 35 days (median 35). FDA has posted 1 recall for KCG devices, 1 initiated in the last five years.

Classification

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

Top KCG applicants

Most recent KCG clearances

Recalls for KCG devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-03.

Frequently asked questions

What is FDA product code KCG?

KCG is the FDA product code for dilator, tracheal. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.

What device class is KCG?

Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 35 days from receipt to decision (median 35).

Which companies have the most KCG clearances?

Kelleher Corp. (1).

Have KCG devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2024-12-03.

Next steps

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