Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Repro-Med Systems, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
294 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102512 | RMS SUBCUTANEOUS NEEDLE SET | Repro-Med Systems, Inc. | 2011-05-20 | 261 | 0 |
| K981506 | RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVI | Repro-Med Systems, Inc. | 1998-06-25 | 59 | 0 |
| K933652 | FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & T | Repro-Med Systems, Inc. | 1994-05-18 | 294 | 1 |
| K894299 | REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM | Repro-Med Systems, Inc. | 1989-09-22 | 92 | 0 |
| K892529 | REPRO-MED NEONATE ASPIRATION SYSTEM | Repro-Med Systems, Inc. | 1989-06-12 | 62 | 0 |
| K844401 | REPRO-MED SYSTEMS INFUSION DEVICE | Repro-Med Systems, Inc. | 1985-03-12 | 119 | 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