Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dpc Cirrus — Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980855 | IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT | Dpc Cirrus | 1998-04-21 | 47 | 1 |
| K970227 | IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER | Dpc Cirrus | 1997-04-08 | 81 | 11 |
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