FDA applicant
Sween Corp.
FDA records 4 decisions for Sween Corp. (N. Mankato, MN) from 1981 to 1993: 4 510(k) clearances. Most are in product codes KMF (Bandage, Liquid) and EXB (Collector, Ostomy). 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 Sween Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Sween Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sween 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