Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Convatec — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
171 daysmedian FDA review time
469 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260737 | Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Fe | Convatec | 2026-08-05 | 152 | 0 |
| K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Cath | Convatec | 2025-07-01 | 116 | 0 |
| K243228 | Flexi-Seal AIR (with ENFit Connector) | Convatec | 2025-03-28 | 171 | 0 |
| K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (C | Convatec | 2024-01-25 | 147 | 0 |
| K162906 | Flexi-Seal PROTECT Fecal Management System | Convatec | 2017-03-07 | 141 | 0 |
| K083785 | VITALA CONTINENCE CONTROL DEVICE | Convatec | 2010-04-02 | 469 | 0 |
| K091034 | AQUACEL AG SURGICAL | Convatec | 2009-12-16 | 250 | 0 |
| K071763 | AMADEUS ADAPTIVE COMPRESSION THERAPY | Convatec | 2008-03-07 | 252 | 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