Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
SAN — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
269 daysmedian FDA review time
1026 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | bioMerieux, Inc. | 2026-07-08 | 169 | 0 |
| K253316 | PhAST instrument and PhAST Blood Culture Gram-negative Panel | Phast Corp. | 2026-06-26 | 269 | 0 |
| K253573 | ASTar BC G- Kit | Q-Linea AB | 2026-04-15 | 149 | 0 |
| K251875 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST sy | Affinity Biosensors, LLC | 2025-10-27 | 131 | 0 |
| K241324 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST sy | Affinity Biosensors, LLC | 2024-10-23 | 166 | 0 |
| K230675 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | Specific Diagnostics, LLC | 2024-06-20 | 468 | 0 |
| K221688 | ASTar BC G- Kit and ASTar Instrument | Q-Linea AB | 2024-04-26 | 686 | 0 |
| K211815 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST Sy | Affinity Biosensors | 2024-04-02 | 1026 | 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