FDA applicant

Marpac, Inc.

Mchenry, IL3 decisions1980–20040 recalls

FDA records 3 decisions for Marpac, Inc. (Mchenry, IL) from 1980 to 2004: 3 510(k) clearances. Most are in product codes KLW (Masker, Tinnitus) and JOH (Tube Tracheostomy And Tube Cuff). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Marpac, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Marpac, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Marpac, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?