Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Danish Diagnostic Development A/S — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
14 daysmedian FDA review time
15 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081829 | CAPIMAGE | Danish Diagnostic Development A/S | 2008-07-11 | 14 | 0 |
| K051460 | C.CAM-AC | Danish Diagnostic Development A/S | 2005-06-15 | 12 | 1 |
| K040616 | CARDIOMD-AC | Danish Diagnostic Development A/S | 2004-03-24 | 15 | 0 |
| K031825 | C.CAM | Danish Diagnostic Development A/S | 2003-06-20 | 7 | 2 |
| K011611 | CARDIOCAM MODEL 9CSY0799 | Danish Diagnostic Development A/S | 2001-06-08 | 14 | 1 |
| K001888 | UNICORN MODEL SYS0630 | Danish Diagnostic Development A/S | 2000-06-30 | 15 | 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