Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
H.S. Hospital Services S.P.A. · 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) |
|---|---|---|---|---|---|
| K131925 | HS NOTA | H.S. Hospital Services S.P.A. | 2014-10-10 | 471 | 0 |
| K013069 | BIOSPEED | H.S. Hospital Services S.P.A. | 2001-12-12 | 90 | 0 |
| K013070 | JAMSHIDI BIOPSY NEEDLE | H.S. Hospital Services S.P.A. | 2001-12-12 | 90 | 0 |
| K013071 | SECURCUT ASPIRATION BIOPSY NEEDLE | H.S. Hospital Services S.P.A. | 2001-12-12 | 90 | 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