Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Convatec, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
168 daysmedian FDA review time
266 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230400 | Cure Catheter Closed System; Cure Dextra Closed System | Convatec, Inc. | 2023-11-08 | 266 | 0 |
| K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus | Convatec, Inc. | 2022-11-17 | 168 | 0 |
| K123481 | AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESI | Convatec, Inc. | 2013-06-06 | 205 | 1 |
| K121275 | AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGT | Convatec, Inc. | 2012-07-25 | 89 | 0 |
| K112342 | FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM | Convatec, Inc. | 2012-04-26 | 255 | 0 |
| K111365 | VITALA CONTINENCE CONTROL DEVICE | Convatec, Inc. | 2011-08-19 | 95 | 0 |
| K102536 | VITALA CONTINENCE CONTROL DEVICE | Convatec, Inc. | 2010-12-01 | 89 | 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