Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biosystems S.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) |
|---|---|---|---|---|---|
| K192730 | CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV | Biosystems S.A. | 2020-09-09 | 348 | 0 |
| K190495 | Transferrin | Biosystems S.A. | 2020-03-16 | 382 | 0 |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCR | Biosystems S.A. | 2019-05-02 | 234 | 0 |
| K170901 | ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, | Biosystems S.A. | 2018-04-13 | 382 | 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