Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cea America Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
740 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942525 | MEDICOUNT DEKA HEMATOLOGY ANALYZER | Cea America Corp. | 1996-06-05 | 740 | 0 |
| K834613 | WILCOR-XR RP MEDICAL FILM | Cea America Corp. | 1984-03-05 | 76 | 0 |
| K834614 | WILCOR-XR RP-L MEDICAL FILM | Cea America Corp. | 1984-03-05 | 76 | 0 |
| K834612 | WILCOR-XR RP-OG MEDICAL FILM | Cea America Corp. | 1984-02-27 | 69 | 0 |
| K834611 | SINGUL-XR RP NON SCREEN MED. FILM | Cea America Corp. | 1984-02-21 | 63 | 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