Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Selux Diagnostics, Inc. — 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) |
|---|---|---|---|---|---|
| K244044 | PBC Separator with Selux AST System | Selux Diagnostics, Inc. | 2025-03-28 | 88 | 0 |
| K223493 | PBC Separator with Selux AST System | Selux Diagnostics, Inc. | 2024-02-15 | 451 | 0 |
| K211748 | Selux AST System; Model AST Gen 1.0 | Selux Diagnostics, Inc. | 2023-04-19 | 681 | 0 |
| K211759 | Selux AST System; Model AST Gen 1.0 | Selux Diagnostics, Inc. | 2023-01-18 | 590 | 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