Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fabersanitas, S.A. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852819 | STERILE DISPOSABLE SYRINGE(3 PIECES) | Fabersanitas, S.A. | 1985-09-20 | 81 | 0 |
| K852818 | STERILE DISPOSABLE SYRINGES(2 PIECES) | Fabersanitas, S.A. | 1985-07-29 | 28 | 0 |
| K852817 | STERILE, DISPOSABLE NEEDLE | Fabersanitas, S.A. | 1985-07-26 | 25 | 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