FDA applicant
Orthion Corp.
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
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.
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.
See the 510(k) Report