Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sween Corp. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K926389 | SWEEN WOUND CARE-COLLAGEN WOUND DRESSING | Sween Corp. | 1993-07-08 | 198 | 0 |
| K912506 | CRITIC-AID WOUND DRESSING | Sween Corp. | 1992-03-02 | 270 | 0 |
| K840723 | SWEEN-A-PEEL PERISTOMAL WAFERS | Sween Corp. | 1984-05-07 | 76 | 0 |
| K810846 | SWEEN UNIVERSAL BED RAIL PADS | Sween Corp. | 1981-04-17 | 21 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda