Data / Medical devices / Nasal Spray, Ent Delivery

Nasal Spray, Ent Delivery (KCO): 59 FDA-registered makers in 15 countries

59 establishments in 15 countries are registered with the FDA to make Nasal Spray, Ent Delivery (product code KCO, Class 1, 21 CFR 874.5220). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on March 10, 1977, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code

KCO

Device class

1

Regulation

874.5220

Medical specialty

Ear, Nose, Throat

Makers by country

Makers of Nasal Spray, Ent Delivery

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated March 10, 1977. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.