Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medi-Dyne, Inc. — 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) |
|---|---|---|---|---|---|
| K000825 | 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER | Medi-Dyne, Inc. | 2000-09-21 | 191 | 1 |
| K970401 | MEDI-DYNE GUIDING CATHETER | Medi-Dyne, Inc. | 1997-08-01 | 179 | 0 |
| K931833 | MODIFIED LUER | Medi-Dyne, Inc. | 1993-09-28 | 204 | 0 |
| K930694 | MEDI-DYNE ANGIOGRAPHIC CATHETER | Medi-Dyne, Inc. | 1993-08-02 | 173 | 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