510(k) Report

FDA applicant

Sween Corp.

N. Mankato, MN4 decisions1981–19930 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

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.

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

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.

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