Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medax Srl Unipersonale — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
241 daysmedian FDA review time
505 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192101 | Medone Ultra, Medextra | Medax Srl Unipersonale | 2020-04-02 | 241 | 0 |
| K192099 | MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspir | Medax Srl Unipersonale | 2020-04-02 | 241 | 0 |
| K181803 | Medax Biopsy Systems III | Medax Srl Unipersonale | 2018-10-18 | 105 | 0 |
| K172344 | Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MED | Medax Srl Unipersonale | 2017-11-13 | 103 | 0 |
| K142125 | New Medax Biopsy Systems | Medax Srl Unipersonale | 2015-12-22 | 505 | 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