Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medegen Medical Manufacturing Services · 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) |
|---|---|---|---|---|---|
| K083765 | MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL | Medegen Medical Manufacturing Services | 2008-12-30 | 12 | 0 |
| K052330 | TRU-SWAB STOCOCK | Medegen Medical Manufacturing Services | 2005-09-09 | 14 | 0 |
| K051930 | DRUG ACCESS SPIKE | Medegen Medical Manufacturing Services | 2005-08-16 | 34 | 0 |
| K051499 | INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET | Medegen Medical Manufacturing Services | 2005-06-22 | 15 | 24 |
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