Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Mediziv Medical Products 1987 , Ltd. · 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) |
|---|---|---|---|---|---|
| K933898 | HUBER NEEDLE SETS | Mediziv Medical Products 1987 , Ltd. | 1995-09-27 | 778 | 0 |
| K933524 | EXTENTION SET | Mediziv Medical Products 1987 , Ltd. | 1995-05-23 | 672 | 0 |
| K933523 | I.V. FILTER SET | Mediziv Medical Products 1987 , Ltd. | 1995-05-19 | 668 | 0 |
| K933522 | INTRODUCER NEEDLE (SEVERAL SIZES) | Mediziv Medical Products 1987 , Ltd. | 1995-02-21 | 581 | 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