510(k) Report

FDA applicant

Lukens Corp.

Mchenry, IL11 decisions1977–19880 recalls

FDA records 11 decisions for Lukens Corp. (Mchenry, IL) from 1977 to 1988: 11 510(k) clearances. Most are in product codes GES (Blade, Scalpel) and KKX (Drape, Surgical, Antimicrobial). 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, general and plastic surgery panel, where it files most

How often FDA has decided Lukens Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lukens Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Lukens”

FDA records each applicant name separately; these may or may not be the same firm.