510(k) Report

FDA applicant

Mcdonald and Assoc., Inc.

Mchenry, IL1 decision1977–19770 recalls

FDA records 1 decision for Mcdonald and Assoc., Inc. (Mchenry, IL) in 1977: 1 510(k) clearance. All are in product code KCO (Nasal Spray, Ent Delivery). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Mcdonald and Assoc., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mcdonald and Assoc., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mcdonald and Assoc., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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