Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Rmds, 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) |
|---|---|---|---|---|---|
| K964663 | FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, | Rmds, Inc. | 1997-12-11 | 385 | 0 |
| K973216 | FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 PO | Rmds, Inc. | 1997-11-25 | 90 | 0 |
| K970027 | FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M20 | Rmds, Inc. | 1997-08-08 | 217 | 0 |
| K964662 | FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000 | Rmds, Inc. | 1997-02-03 | 74 | 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