FDA product code KCO: Nasal Spray, Ent Delivery

KCO is the FDA product code for nasal spray, ent delivery. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under KCO. The average 510(k) review took 175 days (median 175). FDA has posted 1 recall for KCO devices, 1 initiated in the last five years.

Classification

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

Top KCO applicants

Most recent KCO clearances

Recalls for KCO devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-06-23.

Frequently asked questions

What is FDA product code KCO?

KCO is the FDA product code for nasal spray, ent delivery. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel.

What device class is KCO?

Class I, regulation 21 CFR 874.5220. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 175 days from receipt to decision (median 175).

Which companies have the most KCO clearances?

Mcdonald and Assoc., Inc. (1).

Have KCO devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2022-06-23.

Next steps

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