Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Coloplast Manufacturing Us, LLC — 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) |
|---|---|---|---|---|---|
| K100878 | SELF CATH CATHETER | Coloplast Manufacturing Us, LLC | 2010-05-26 | 57 | 0 |
| K093112 | DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE | Coloplast Manufacturing Us, LLC | 2010-02-01 | 123 | 0 |
| K082640 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM | Coloplast Manufacturing Us, LLC | 2008-10-17 | 37 | 0 |
| K070939 | SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM | Coloplast Manufacturing Us, LLC | 2007-06-01 | 58 | 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