Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EXE · 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) |
|---|---|---|---|---|---|
| K904233 | CONVATEC ABSORBENT BANDAGE | Convatec, A Division of E.R. Squibb & Sons | 1991-03-06 | 182 | 0 |
| K770982 | UNITED SKIN BARRIER | Howmedica Corp. | 1977-07-15 | 45 | 0 |
| K760927 | STOMA SHIELD ADAPTER | Rudolfo T. Sanchez | 1977-01-26 | 90 | 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