Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NIJ — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
422 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243405 | Xpert vanA | Cepheid® | 2024-11-21 | 20 | 0 |
| K123753 | IMDX VANR FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | 2013-07-17 | 223 | 0 |
| K102416 | BD GENEOHM VANR ASSAY | Bd Diagnostics Science | 2011-10-20 | 422 | 0 |
| K092953 | Xpert VanA Assay | Cepheid | 2009-12-17 | 84 | 0 |
| K061686 | IDI-VANR ASSAY | Geneohm Sciences Canada, Inc. | 2006-08-30 | 76 | 0 |
| K020576 | VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE | Id Biomedical Corp. | 2002-05-01 | 69 | 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