Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NQI — Predicate Candidate Screening
13 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
150 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130794 | CELLTRACKS ANALYZER II SYSTEM | Veridex, LLC | 2013-06-20 | 90 | 1 |
| K122821 | CELLTRACKS AUTOPREP SYSTEM | Veridex, LLC | 2012-12-13 | 90 | 2 |
| K110406 | CELLTRACKS AUTOPREP SYSTEM | Veridex, LLC | 2012-01-20 | 340 | 2 |
| K113181 | CELLTRACKS ANALYER II | Veridex, LLC | 2011-12-12 | 45 | 1 |
| K103502 | CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 | Veridex, LLC | 2010-12-21 | 22 | 1 |
| K073338 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2008-02-26 | 90 | 1 |
| K071729 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2007-11-20 | 148 | 0 |
| K062013 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2006-12-14 | 150 | 1 |
| K060110 | CELLTRACKS ANALYZER II | Immunicon Corp. | 2006-03-16 | 58 | 1 |
| K052191 | MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2005-10-27 | 77 | 1 |
| K050145 | CELLTRACKA ANALYZER II | Immunicon Corp. | 2005-03-15 | 50 | 2 |
| K050245 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2005-03-15 | 41 | 1 |
| DEN040001 | CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTE | Advanced Diagnostic Systems | 2004-01-21 | 19 | 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