510(k) Report

FDA applicant

Duro-Med Ind., Inc.

Mchenry, IL2 decisions1980–19830 recalls

FDA records 2 decisions for Duro-Med Ind., Inc. (Mchenry, IL) from 1980 to 1983: 2 510(k) clearances. Most are in product codes KIC (Cushion, Flotation) and IMA (Pack, Heat, Moist). 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, physical medicine panel, where it files most

How often FDA has decided Duro-Med Ind., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Duro-Med Ind., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Duro-Med Ind., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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