Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Plastimed Laboratoire Pharmaceutique · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992424 | SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN L | Plastimed Laboratoire Pharmaceutique | 2000-12-29 | 527 | 0 |
| K974642 | COMBICATH CATHETER | Plastimed Laboratoire Pharmaceutique | 1998-03-13 | 88 | 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