Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gerard Medical, 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) |
|---|---|---|---|---|---|
| K974533 | TRIMPORT | Gerard Medical, Inc. | 1998-05-07 | 156 | 0 |
| K972555 | CATHETER TUNNELER | Gerard Medical, Inc. | 1997-12-22 | 168 | 0 |
| K945060 | HERNIA MESH INTRODUCTION SYSTEM | Gerard Medical, Inc. | 1995-03-02 | 139 | 0 |
| K936207 | ENDO-NEEDLE INSTRUMENT | Gerard Medical, Inc. | 1994-06-16 | 169 | 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