Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
BWP · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880384 | KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT | Kimberly-Clark Corp. | 1988-06-23 | 147 | 0 |
| K831952 | SURGICAL APPAREL SHOE COVERS | Sudreca Surgical Dressings, Inc. | 1983-07-12 | 27 | 0 |
| K812105 | ANOGO DISPOSABLE SHOE COVER | Anago, Inc. | 1981-09-11 | 49 | 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