Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Repro-Med Systems, Inc. Dba Rms Medical Products · 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) |
|---|---|---|---|---|---|
| K180843 | HIgH-Flo Super26 Subcutaneous Needle Sets | Repro-Med Systems, Inc. Dba Rms Medical Products | 2019-04-04 | 367 | 0 |
| K162613 | Integrated Catch-up Freedom Syringe Driver Infusion System | Repro-Med Systems, Inc. Dba Rms Medical Products | 2017-08-31 | 346 | 0 |
| K122404 | MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RM | Repro-Med Systems, Inc. Dba Rms Medical Products | 2013-05-06 | 272 | 1 |
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