510(k) Report

FDA applicant

Orthion Corp.

Mchenry, IL11 decisions1981–19830 recalls

FDA records 11 decisions for Orthion Corp. (Mchenry, IL) from 1981 to 1983: 11 510(k) clearances. Most are in product codes IKX (Aid, Transfer) and ILS (Adaptor, Hygiene). 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 Orthion Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthion Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Orthion Corp.’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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