Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Convatec, Ltd. — 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) |
|---|---|---|---|---|---|
| K150350 | Flexi-Seal Signal Fecal Management System | Convatec, Ltd. | 2015-07-21 | 160 | 0 |
| K140953 | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETE | Convatec, Ltd. | 2014-08-01 | 109 | 0 |
| K973688 | DUODERM CONTROL GEL FORMULA BORDER DRESSING | Convatec, Ltd. | 1997-12-23 | 88 | 0 |
| K973689 | DUODERM HYDROACTIVE DRESSING | Convatec, Ltd. | 1997-12-23 | 88 | 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