Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EZQ · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
469 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111365 | VITALA CONTINENCE CONTROL DEVICE | Convatec, Inc. | 2011-08-19 | 95 | 0 |
| K102536 | VITALA CONTINENCE CONTROL DEVICE | Convatec, Inc. | 2010-12-01 | 89 | 0 |
| K083785 | VITALA CONTINENCE CONTROL DEVICE | Convatec | 2010-04-02 | 469 | 0 |
| K922401 | 4 SURE TM COLOSTOMY POUCH | Boston Pacific Medical, Inc. | 1992-06-10 | 20 | 0 |
| K880327 | MARLEN ULTRA ILEOSTOMY POUCH-5000 | Marlen Mfg. & Development Co. | 1988-02-19 | 24 | 0 |
| K863830 | CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM | Coloplast A/S | 1986-10-16 | 16 | 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