FDA product code KCB: Tube, Tonsil Suction

KCB is the FDA product code for tube, tonsil suction. 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 KCB. The average 510(k) review took 49 days (median 49). FDA has posted 1 recall for KCB devices, 1 initiated in the last five years.

Classification

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

Top KCB applicants

Most recent KCB clearances

Recalls for KCB devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-04-08.

Frequently asked questions

What is FDA product code KCB?

KCB is the FDA product code for tube, tonsil suction. 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 KCB?

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

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

Across 1 cleared submissions the average was 49 days from receipt to decision (median 49).

Which companies have the most KCB clearances?

Edward Weck, Inc. (1).

Have KCB devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2024-04-08.

Next steps

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