FDA applicant
The Owenby Co.
FDA records 14 decisions for The Owenby Co. (Mchenry, IL) from 1976 to 1980: 14 510(k) clearances. Most are in product codes FYF (Cap, Surgical) and FQM (Bandage, Elastic). 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 The Owenby Co.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for The Owenby Co. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like The Owenby Co.’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