Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
R-Med, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
315 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001236 | RIZA BAND STRETCHER (RBS)-60000 | R-Med, Inc. | 2000-07-17 | 90 | 0 |
| K953360 | R-MED ABDOMINAL WALL ELEVATOR | R-Med, Inc. | 1996-01-11 | 178 | 0 |
| K954882 | RIZA-RIBE NEEDLE (MODIFICATION) | R-Med, Inc. | 1995-11-16 | 98 | 0 |
| K953441 | RIZA-RIBE NEEDLE | R-Med, Inc. | 1995-08-18 | 32 | 0 |
| K950108 | R-MED MINI-RETRACTOR | R-Med, Inc. | 1995-05-11 | 120 | 0 |
| K942411 | R-MED DISPOSABLE PLUG | R-Med, Inc. | 1995-03-31 | 315 | 0 |
| K945637 | R-MED MOTORIZED LAPAROSCOPIC HANDLE | R-Med, Inc. | 1994-12-07 | 21 | 0 |
| K943818 | MANUAL LAPAROSOPIC HANDLE, INTERCHANGEABLE LAPAROSCOPIC TOOL | R-Med, Inc. | 1994-08-29 | 24 | 0 |
| K935031 | RIZA-RIBE NEEDLE | R-Med, Inc. | 1994-04-25 | 187 | 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