Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rd Medical Mfg., 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) |
|---|---|---|---|---|---|
| K010538 | PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PA | Rd Medical Mfg., Inc. | 2001-03-30 | 35 | 0 |
| K001102 | PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E | Rd Medical Mfg., Inc. | 2000-04-20 | 15 | 0 |
| K000017 | PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E | Rd Medical Mfg., Inc. | 2000-02-10 | 38 | 0 |
| K992104 | PARSET, MODEL A10001E | Rd Medical Mfg., Inc. | 1999-08-23 | 62 | 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