Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mri Manufacturing and Research, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083685 | ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82X | Mri Manufacturing and Research, Inc. | 2009-06-25 | 195 | 0 |
| K982970 | MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER | Mri Manufacturing and Research, Inc. | 1998-10-28 | 64 | 0 |
| K944676 | MRI'S ALL SILICONE FOLEY CATHETER | Mri Manufacturing and Research, Inc. | 1996-04-05 | 561 | 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