Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnostica Stago S.A.S · 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) |
|---|---|---|---|---|---|
| K212183 | STA R Max 3, STA Compact Max 3 | Diagnostica Stago S.A.S | 2023-06-07 | 694 | 0 |
| K211485 | STA- NeoPTimal | Diagnostica Stago S.A.S | 2022-12-23 | 589 | 0 |
| K151867 | STA R MAX | Diagnostica Stago S.A.S | 2015-08-07 | 29 | 1 |
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