Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Immunicon Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
301 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060110 | CELLTRACKS ANALYZER II | Immunicon Corp. | 2006-03-16 | 58 | 1 |
| K050145 | CELLTRACKA ANALYZER II | Immunicon Corp. | 2005-03-15 | 50 | 2 |
| K040077 | IMMUNICON CELLTRACKS AUTOPREP SYSTEM | Immunicon Corp. | 2004-03-12 | 58 | 2 |
| K030263 | IMMUNICON CELLTRACKS ANALYZER | Immunicon Corp. | 2003-11-24 | 301 | 0 |
| K030596 | IMMUNICON CELLSAVE PRESERVATIVE TUBE | Immunicon Corp. | 2003-08-08 | 164 | 0 |
| K022512 | CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 | Immunicon Corp. | 2002-09-30 | 62 | 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