Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Convatec, A Division of E.R. Squibb & Sons, LLC · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090254 | SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON | Convatec, A Division of E.R. Squibb & Sons, LLC | 2009-09-04 | 214 | 0 |
| K080383 | AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING | Convatec, A Division of E.R. Squibb & Sons, LLC | 2008-05-02 | 80 | 0 |
| K063271 | AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER S | Convatec, A Division of E.R. Squibb & Sons, LLC | 2007-04-16 | 168 | 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