FDA product code KAK: Probe, Ent

KAK is the FDA product code for probe, ent. 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 KAK. The average 510(k) review took 27 days (median 27). FDA has posted 1 recall for KAK devices.

Classification

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

Top KAK applicants

Most recent KAK clearances

Recalls for KAK devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-08-17.

Frequently asked questions

What is FDA product code KAK?

KAK is the FDA product code for probe, ent. 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 KAK?

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

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

Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).

Which companies have the most KAK clearances?

Kelleher Corp. (1).

Have KAK devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2012-08-17.

Next steps

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